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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97075

46 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 10, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SEDECAL SA

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

46 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 46

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

Z-0242-2026
Recall number
Z-0242-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846.

Distribution pattern

US: CA, IL, and NJ

device · product 2 of 46

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

Z-0243-2026
Recall number
Z-0243-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15100127, 15100131, 15100135, 15100138, 15100144, 15100133, 14100034, SN14000127, 15100191, 66690596, 66936848, 15100274, 15100280, 15100276, SN16100008, 16100011, 67905914, 16100037, 16100038, 68025890, 68052381, 68054442, 68199970, 68233849, 68268597, 12000085, 68530038, 16200084, 16200028, 16200029, 16200049, 16200050, 16200051, 69022933, 16200064, 16200099, 70240554, 70378102, 70544668, 70545417, 70705340, 71001729, 72299716, 72555189, 21410094, 21410261, 21410347, 21410348, 22410146, 97579477, 97808946, 22410333, 17200007, 17200002, SN16200130, 16200129, 70929667, 16200137, 16200136, SN17200073, SN17200056, SN17200131, SN17200140, SN17200162, SN17200161, SN17200174, SN17200173, SN17200175, SN17200168, SN17200167, 16200049, SN17200217, 17200167, 17200168, SN18200010, SN18200011, SN18200049, SN18200088, SN18200112, SN18200133, SN18200124, 74854394, 75716470, SN18200176, SN18200186, SN18200209, SN18200341, 18200206, 18200205, SN19300073, SN19300085, SN19300098, 16, SN19300035, SN19300088, SN19300091, SN19300099, SN19300109, 23410012, SN21410184, SN19410126, 27, SN19410129, 23410046, 19410044, 19410046, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410320, 21410329, 21410330, 21410331, 21410332, 21410333, 21410334, 21410339, 21410340, 21410341, 21410342, 21410345, 21410349, 21410351, 21410360, 21410361, 21410362, 21410363, 21410365, 21410366, 21410367, 21410368, 21410369, 21410378, 21410379, 21410383, 21410384, 21410394, 21410402, 21410409, 21410410, 21410413, 21410414, 21410436, 22410002, 22410003, 22410021, 22410022, 22410023, 22410032, 22410033, 22410034, 22410035, 22410036, 22410050, 22410093, 22410121, 22410122, 22410132, 22410133, 22410142, 22410143, 22410145, 22410152, 22410153, 22410154, 22410155, 22410158, 22410159, 22410160, 22410161, 22410163, 22410164, 22410165, 22410189, 22410194, 22410195, 22410196, 22410197, 22410198, 22410199, 22410200, 22410201, 22410202, 22410203, 22410204, 22410218, 22410219, 22410226, 22410229, 22410236, 22410237, 22410238, 22410239, 22410245, 22410246, 22410247, 22410248, 22410251, 22410253, 22410315, 22410317, 22410318, 22410319, 22410320, 22410321, 22410322, 22410328, 22410331, 22410332, 23410008, 23410009, 23410010, 23410027, 23410040, 23410043, 23410044, 23410045, 23410047, 23410071, 23410072, 23410073, 23410078, 23410079, 23410080, 23410081, 23410086, 23410087, 23410088, 23410089, 23410090, 23410091, 23410092, 23410099, 23410102, 23410108, 23410120, 23410121, 23410122, 23410124, 23410125, 23410128, 23410133, 23410134, 23410135, 23410138, 23410139, 23410152, 23410164, 23410167, 23410171, 23410172, 23410174, 23410175, 23410176, 23410177, 23410193, 23410247, 23410257, 23410269, 23410270, 24410107, 24410146, 24410148, 24410149, 24410151, 24410168, 214410346, 214411180, 214411229, 23410118, SN0410157, SN1410049, SN19410034, SN19410035, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, 20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410103, SN21410104, SN21410105, 21410117, SN21410118, SN21410119, SN21410130, SN21410131, 21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, 21410213, 21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, SNZY204110015, 485059/SN11000013, 485060/SN11000015, 485062/SN11000009, 485061/SN11000012, 488170/SN11000010, 488169/SN11000011, 489089/SN11000016, 489694/SN11000035, 489696/SN11000037, 489616/SN11000033, 490027/SN11000034, 489695/SN11000036, 489088/SN11000040, 490221/SN11000039, 492411/SN11000014, 492417/SN11000048, 493565/SN11000048, 493566/SN11000047, 494456/SN11000055, 494941/SN11000052, 494464/SN11000065, 488171/SN11000068, 494864/SN11000060, 494865/SN11000056, 494866/SN11000062, 494867/SN11000051, 495286/SN11000061, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494064/SN11000074, 494065/SN11000075, 494063/SN11000073, 496446/SN11000082, 496448/SN11000057, 497570/SN11000066, 496387/SN12000003, 497715/SN11000080, 495938/SN12000007, 12000008, 493364/SN12000022, 493462/SN12000023, 500740/SN12000028, 501028/SN12000026, 500739/SN12000027, 502424/SN12000034, 503141/SN12000038, 503142/SN12000037, 503143/SN12000036, 503144/SN12000039, 503380/SN12000044, 502721/SN12000047, 505077/SN12000048, 500466/SN12000045, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 496401/SN12000059, 500467/SN12000060, 500468/SN12000058, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 509633/SN12000069, 509640/SN12000071, 510607/SN12000072, 512879/SN12000076, 512160/SN12000077, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 512892/SN12000082, 508699/SN12000088, 514103/SN12000092, 514104/SN12000091, 514461/SN12000090, 514462/SN12000089, 513477/SN12000080, 513478/SN12000081, 516891/SN12000110, 516896/SN12000111, 509062/SN12000107, 497572/SN12000112, 508783/SN12000108, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 519762/SN13000018, 520251/SN13000016, 519506/SN13000011, 520253/SN13000017, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520416/SN13000031, 520252/SN13000027, 520421/SN13000032, 520422/SN13000028, 520417/SN13000033, 520418/SN13000030, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000060, 13000054, 13000056, 13000058, 13000057, 13000055, SN13000074, 13000075, 13000070, 13000071, SN13000073, SN13000069, SN13000072, 13000077, 13000078, SN13000084, SN13000083, SN13000091, 13000090, SN13000104, SN13000107, SN13000106, SN13000102, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000142, 13000141, 13000140, 13000139, 13000143, 13000144, SN13000147, SN13000154, SN13000153, 13000158, SN13000157, SN13000160, SN13000164, 13000177, 13000163, SN13000176, 13000165, SN13000174, SN13000180, SN13000183, SN13000185, SN13000182, 14000010, 13000199, 13000196, SN13000206, 13000203, 13000205, 13000204, 14000004, 14000005, 13000202, 14000006, 14000024, 14000022, 14000028, 14000032, 14000031, 14000029, 14000033, 14000034, 14000037, 14000038, 14000046, 14000048, 14000050, SN14000061, 14000069, 14000075, 14000072, 14000077, 14000080, 14000079, 14000081, 14000078, 14000084, 14000082, 14000086, 14000087, 14000088, 14000089, 14000043, SN14000098, SN14000099, SN14000100, 14000103, 14000106, 14000085, 14000112, 14000120, 14000121, 14000122, 14000124, 14000127, 14000092, SN14100071, SN14100072, SN14100073, SN14000130, SN14100074, SN14100075, SN14100047, 14100053, SN14100046, 14100044, 14100045, SN14100055, 14100054, 14000134, 14100087, 14100086, 14100088, 14100085, 14000135, 14100090, 14100097, 14100094, 14100095, 14100101, 14100109, 14100111, 14000138, 14000139, 14100117, 14100126, 14100128, 14100127, SN15100009, SN15100011, SN15100016, SN15100018, SN15100020, SN15000002, 15100023, 15100019, 15100034, 15100048, 15100047, 15100036, 15100035, 15100050, 15100028, 15100071, 15100039, 15100084, 15100085, 15100089, 15100088, 15100094, 15100091, 15100092, 15100087, 15100093, 15100098, 15100097, 15100099, 15100103, 15100101, 15100122, 15100121, 15100120, 15100119, 15100118, 15100128, 15100129, 15100117, 15100123, 15100130, 15100132, 15100139, 15100140, 15100137, 15100134, 15100136, SN15100150, SN15100148, SN15100149, SN15100153, SN15100030, SN15100151, SN15100158, SN15100155, SN15100157, 15100166, 15100162, 15100165, 15100169, 15100172, 15100171, 15100173, 15100178, 15100170, 15100161, 15100168, SN15100179, SN15100181, SN14000126, 15100195, 15100196, 15100211, 15100214, 15100219, 15100222, 15100223, 15100227, 15100228, 15100229, 15100230, 15100233, 15100238, 15100253, 15100249, SN15100255, SN15100260, 15100266, 15100268, 15100270, 15100271, 15100273, 15100275, 15100277, 16100005, 16100007, SN16100012, 16100028, 16100029, 16100033, 16100034, 16100041, 16100042, 16100045, 16100047, 16100049, 16100061, 16100062, 16100065, 16200010, 16200030, 16200033, 16200027, 16200034, 16200036, 16200045, 16200046, 16200052, 16200058, 16200059, 16200057, 16200043, 16200062, 16200063, 16200065, 16200069, 16200076, SN16200077, 16200078, 16200074, 16200075, 16200089, 16200085, 16200086, 16200087, 16200101, 16200102, 16200103, 16200107, 16200108, 16200135, 16200127, SN16200126, 16200138, 16200139, 16200140, 16200157, 16200152, 16200159, 17200003, 17200004, 17200005, 17200006, 17200011, 17200014, 17200019, 17200020, 17200024, 17200025, 17200027, 17200026, 17200033, 17200030, 17200032, 17200038, 17200043, 17200037, SN17200049, 17200058, 71573917, 17200060, 17200061, SN17200055, 17200059, SN17200066, SN17200067, SN17200072, SN17200083, SN17200082, SN17200084, SN17200087, 17200086, SN17200089, SN17200088, SN17200096, SN17200097, SN17200100, SN17200101, SN17200102, SN17200098, SN17200099, SN17200091, SN17200106, SN17200112, SN17200113, 17200114, SN17200115, SN17200121, SN17200123, SN17200126, SN17200125, SN17200130, SN17200129, SN17200128, SN17200127, SN17200134, SN17200135, SN17200138, SN17200137, SN17200139, SN17200136, SN17200152, SN17200160, SN17200159, SN17200158, SN17200177, SN17200176, SN17200172, SN17200171, SN17200157, SN17200166, 17200165, SN17200164, SN17200163, SN17200181, SN17200189, SN17200187, SN17200192, SN17200191, SN17200188, SN17200182, SN17200204, SN17200205, SN17200207, SN17200202, SN17200201, SN17200196, SN17200195, SN17200219, SN17200194, SN17200197, SN17200220, SN17200200, SN17200224, SN17200198, SN17200237, SN17200236, 17200235, SN17200239, SN18200009, SN18200008, SN18200007, 18200042, SN18200040, SN18200041, 8200039, SN18200013, SN18200036, 18200044, 18200031, 18200047, 18200033, SN18200037, 18200045, 18200046, 18200038, 18200048, SN18200034, SN18200012, SN18200043, SN18200058, SN18200059, SN18200032, SN18200061, SN18200057, 18200056, SN18200068, SN18200071, SN18200081, SN18200082, SN18200084, SN18200086, SN18200085, SN18200072, SN18200116, SN18200117, SN18200035, SN18200067, SN18200096, SN18200110, SN18000087, SN18200127, SN18200070, SN18200139, SN18200138, SN18200095, SN18200109, SN18200123, SN18200137, SN18200140, SN18200141, SN18200159, SN18200154, SN18200160, 18200171, SN18200169, SN18200161, SN18200167, SN18200166, SN18200165, SN18200173, SN18200175, SN18200174, SN18200183, SN18200185, SN18200187, SN18200208, SN18200203, SN18200205, SN18200206, SN18200189, SN18200194, SN18200211, SN18200215, SN18200200, SN18200216, SN18200217, SN18200218, SN18200219, SN18200222, SN18200231, SN18200244, SN18200210, SN18200232, SN18200233, SN18200234, SN18200254, SN18200256, SN18200257, SN18200261, SN18200259, SN18200258, SN18200271, SN18200260, SN18200288, SN18200292, SN18200310, SN18200315, SN18200314, SN18200245, SN18200332, SN18200334, SN18200236, SN18200237, SN18200335, SN18200337, SN18200344, SN18200343, SN19300001, SN19300002, SN19300030, SN19300007, SN19300023, SN19300026, SN19300032, SN19300033, SN19300040, SN19300043, SN19300028, SN19300024, SN19300063, SN19300044, SN19300066, SN19300067, SN19300016, SN19300070, SN19300076, SN19300075, SN19300074, SN19300072, SN19300005, SN19300077, 24410156, 24410155, 24410154, 24410153, 24410152, 24410150, 24410147, 24410145, 24410144, 24410143, 24410142, 24410141, 25410027, 25410026, 25410024, 25410023, 25410022, 25410021, 25410018, 25410017, 25410016, 25410015, 25410014, 25410013, 25410012, 25410011, 25410010, 25410009, 25410008, 25410007, 25410005, 25410004, 25410003, 25410002, 25410001, 24410185, 24410184, 24410183, 24410181, 24410180, 24410176, 24410175, 24410174, 24410172, 24410171, 24410170, 24410162, 24410161, 24410160, 24410035, 24410028, 24410025.

Distribution pattern

US: CA, IL, and NJ

device · product 3 of 46

Model Number 40KWFX, Mobile X-ray system

Z-0244-2026
Recall number
Z-0244-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G71453, G70953, G70930, G70537, G70757, G70797, G70275, G71257, G71983, G71975, G71467, G69702, G71440, G71329, G70244, G70955, G71462, G71320, G71451, G71466, G71335, G71446, G65260, G70951, G70814, G70931, G70942, G71991, G70261, G72080, G69697, G71978, G70938, G70247, G70250, G70947, G69706, G78917, G70943, G71343, G71345, G71346, G71258, G70527, G69551, G71442, G71977, G71987, G72083, G70242, G72111, G70256, G70806, G71339, G69547.

Distribution pattern

US: CA, IL, and NJ

device · product 4 of 46

Model Number 40KW-FX.899, Mobile X-ray system

Z-0245-2026
Recall number
Z-0245-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G72770

Distribution pattern

US: CA, IL, and NJ

device · product 5 of 46

Model Number 40KWFXPLUS, Mobile X-ray system

Z-0246-2026
Recall number
Z-0246-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
268 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017, G80154, G73616, G73471, G76479, G79615, G80179, G79467, G79827, G79840, G79877, G79926, G78011, G78726, G82574, G82638, G73651, G75438, G77820, G78050, G79426, G79634, G82590, G72392, G73520, G73524, G73627, G73642, G73653, G76730, G76888, G78212, G78279, G78296, G78305, G78323, G82156, G83117, G83133, G73624, G82557, G84603, G84633, G84634, G84641, G84642, G84753, G84778, G84795, G84857, G84869, G84882, G84884, G84900, G84901, G84902, G84911, G84912, G85513, G85514, G85516, G85527, G85528, G79115, G79915, G72362, G75112, G75515, G79299, G79324, G73453, G79625, G77328, G75676, G75744, G75439, G78129, G78141, G76110, G76545, G78000, G80042, G73460, G75100, G75502, G84782, G79794, G83972, G84025, G79936, G84487, G75404, G73457, G75085, G79927, G75388, G73609, G76560, G78992, G82079, G82095, G84014, G75375, G75503, G75516, G73621, G73648, G72971, G77213, G79889, G77605, G79311, G75961, G77789, G84028, G73015, G73063, G78873, G79663, G79275, G73027, G76887, G79277, G79357, G76126, G75980, G76125, G76844, G77073, G77089, G77191, G77425, G73079, G75867, G83920, G84017, G77609, G77653, G84591, G75904, G75905, G73147, G73059, G77583, G77641, G77768, G77854, G77870, G77928, G84038, G72363, G73052, G75661, G75662, G75691, G84052, G72972, G73084, G73119, G76757, G76803, G84066, G77780, G73040, G73038, G73139, G75705, G76156, G76721, G84064, G79616, G82140, G82141, G82159, G83203, G75012, G79183, G79806, G70809, G79037, G79182, G80186, G76831, G77408, G79899, G82499, G75451, G75111, G73469, G82158, G80068, G84867, G75114, G75437, G77338, G76250, G77218, G77394, G79432, G79025, G83227, G79102, G79427, G77788, G75011, G75039, G83228, G79060, G78090, G80244, G80090, G82558, G76109, G72422, G75422, G76285, G77178, G78009, G78023, G78052, G78062, G78080, G78697, G78713, G78749, G78896, G79585, G79623, G82157, G83105, G83137, G77144, G75592, G76234, G76579, G78947, G77123, G82591, G78962, G79105, G80180, G79341, G79393, G84754, G76439, G75387, G73463, G73472, G79297, G80153.

Distribution pattern

US: CA, IL, and NJ

device · product 6 of 46

Model Number 40KWFXPLUS.002, Mobile X-ray system

Z-0247-2026
Recall number
Z-0247-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G73508, G73512, G71323, G72419, G78910, G72425, G83214, G70934.

Distribution pattern

US: CA, IL, and NJ

device · product 7 of 46

Model Number 40KWFXPLUS.004, Mobile X-ray system

Z-0248-2026
Recall number
Z-0248-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI unknown, Serial Numbers: G84489, G84504, G84589.

Distribution pattern

US: CA, IL, and NJ

device · product 8 of 46

Model Number 40KWFXPLUS.005, Mobile X-ray system

Z-0249-2026
Recall number
Z-0249-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G82576, G82871, G72391, G74872, G75722, G76782, G75035, G75723, G78884, G70532, G73630, G82077.

Distribution pattern

US: CA, IL, and NJ

device · product 9 of 46

Model Number 40KWFXPLUS.889, Mobile X-ray system

Z-0250-2026
Recall number
Z-0250-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G77146

Distribution pattern

US: CA, IL, and NJ

device · product 10 of 46

Model Number 40KWFXPLUS-710CW, Mobile X-ray system

Z-0251-2026
Recall number
Z-0251-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605.

Distribution pattern

US: CA, IL, and NJ

device · product 11 of 46

Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system

Z-0252-2026
Recall number
Z-0252-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G79192, G79195, G79212, G78205, G80256, G79692, G80053.

Distribution pattern

US: CA, IL, and NJ

device · product 12 of 46

Model Number 40KWMOBILE3.899, Mobile X-ray system

Z-0253-2026
Recall number
Z-0253-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI unknown, Serial Numbers: G64852

Distribution pattern

US: CA, IL, and NJ

device · product 13 of 46

Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

Z-0254-2026
Recall number
Z-0254-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001091, Serial Numbers: G23218

Distribution pattern

US: CA, IL, and NJ

device · product 14 of 46

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

Z-0255-2026
Recall number
Z-0255-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI unknown, Serial Numbers: G22915, G23633, G23828, G20560, G21319, G24800, G19667, G20347.

Distribution pattern

US: CA, IL, and NJ

device · product 15 of 46

Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system

Z-0256-2026
Recall number
Z-0256-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001466, Serial Numbers: G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, G38069, G-40590, G41143, G62020, G69393, G38082, G41163, G60166, G26244, G40196, G60461, G33309.

Distribution pattern

US: CA, IL, and NJ

device · product 16 of 46

Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system

Z-0257-2026
Recall number
Z-0257-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G-33126, G31259, G35641, G35630, G35718, G37357.

Distribution pattern

US: CA, IL, and NJ

device · product 17 of 46

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

Z-0258-2026
Recall number
Z-0258-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684.

Distribution pattern

US: CA, IL, and NJ

device · product 18 of 46

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

Z-0259-2026
Recall number
Z-0259-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G37528

Distribution pattern

US: CA, IL, and NJ

device · product 19 of 46

Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

Z-0260-2026
Recall number
Z-0260-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G13768, G36626, G62493, G39518, G61725, G36211, G36281, G36573, G36581, G61368, G61880, G62037, G61367, G36227.

Distribution pattern

US: CA, IL, and NJ

device · product 20 of 46

Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system

Z-0261-2026
Recall number
Z-0261-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001114, Serial Numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240.

Distribution pattern

US: CA, IL, and NJ

device · product 21 of 46

Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

Z-0262-2026
Recall number
Z-0262-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001527, Serial Numbers: 151248, G23340, C05006-W, G22215, G27497/584, 7034, G25402, G25910.

Distribution pattern

US: CA, IL, and NJ

device · product 22 of 46

Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system

Z-0263-2026
Recall number
Z-0263-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G32487, 31414, G35462, G32657.

Distribution pattern

US: CA, IL, and NJ

device · product 23 of 46

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

Z-0264-2026
Recall number
Z-0264-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI unknown, Serial Numbers:G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570, G31077, G29426, G33144, G29416, G30160, G30685, G33723, G30165.

Distribution pattern

US: CA, IL, and NJ

device · product 24 of 46

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

Z-0265-2026
Recall number
Z-0265-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G35462, G-32753, G35480, G33111, G33721.

Distribution pattern

US: CA, IL, and NJ

device · product 25 of 46

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

Z-0266-2026
Recall number
Z-0266-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G33585

Distribution pattern

US: CA, IL, and NJ

device · product 26 of 46

Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system

Z-0267-2026
Recall number
Z-0267-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G-33103, G35422, G35504, G33127, G33646.

Distribution pattern

US: CA, IL, and NJ

device · product 27 of 46

Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system

Z-0268-2026
Recall number
Z-0268-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G35524, G33711.

Distribution pattern

US: CA, IL, and NJ

device · product 28 of 46

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

Z-0269-2026
Recall number
Z-0269-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G37587.

Distribution pattern

US: CA, IL, and NJ

device · product 29 of 46

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

Z-0270-2026
Recall number
Z-0270-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G35611, G37536, G37588, G37490.

Distribution pattern

US: CA, IL, and NJ

device · product 30 of 46

Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

Z-0271-2026
Recall number
Z-0271-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
181 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892, G62943, G41083, G41100, G36217, G36537, G60066, G61812, G61812, G63322, G40016, G41203, G41222, G60061, G60063, G60064, G36732, G36751, G41119, G62480, G60418, G61707, G65172, G39639, G41104, G36526, G36601, G37129, G37209, G41244, G62015, G40024, G62828, G60429, G61818, G61873, G60065, G61786, G37430, G36148, G39650, G64186, G65400, G64854, G62626, G62660, G62684, G62687, G62747, G62750, G62762, G62938, G63484, G62804, G64206, G64813, G64179, G62500, G62502, G62565, G62690, G62860, G62867, G62883, G62891, G62947, G36222, G60415, G60070, G37646, G61715, G39589, G37466, G38292, G38173, G38058, G38293, G60069, G62816, G63335, G36244, G36492, G37442, G38613, G40124, G40211, G38190, G40199, G62567, G39809, G38287, G37196, G41256, G61872, G62029, G64891, G62682, G62900, G61311, G37239, G38279, G37678, G38076, G61307, G39808, G40133, G62821, G64883, G60058, G60062, G61867, G37676, G40203, G37422, G62815, G36468, G37413, G40216, G41058, G41066, G63212, G41267, G40227, G60430, G63318, G63328, G63333, G41108, G41109, G61716, G60518, G60652, G61356, G60520, G60597, G39800, G39801, G60582, G39657, G62030, G65393, G65395, G39782, G39791, G61706, G61795, G62053, G62062, G62011, G64512, G64520, G65289, G60576, G60606, G60631, G61339, G39465, G61333, G61337, G38629, G62511, G41218, G60635.

Distribution pattern

US: CA, IL, and NJ

device · product 31 of 46

Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system

Z-0272-2026
Recall number
Z-0272-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G62066

Distribution pattern

US: CA, IL, and NJ

device · product 32 of 46

Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system

Z-0273-2026
Recall number
Z-0273-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G37158, G61698, G62863, G41192, G62814, G41098, G62566, G60400, G63392, G60406.

Distribution pattern

US: CA, IL, and NJ

device · product 33 of 46

Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system

Z-0274-2026
Recall number
Z-0274-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G39822, G62662, G62564, G61702, G60067, G38060.

Distribution pattern

US: CA, IL, and NJ

device · product 34 of 46

Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system

Z-0275-2026
Recall number
Z-0275-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G41234

Distribution pattern

US: CA, IL, and NJ

device · product 35 of 46

Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system

Z-0276-2026
Recall number
Z-0276-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G36566

Distribution pattern

US: CA, IL, and NJ

device · product 36 of 46

Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system

Z-0277-2026
Recall number
Z-0277-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
142 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G65281, G60407, G65682, G64582, G64789, G70752, G65384, G65418, G67250, G68470, G70521, G70524, G70913, G70914, G65166, G63507, G64205, G64842, G71447, G65175, G65382, G64793, G64798, G40226, G72434, G65554, G67230, G37280, G65174, G65558, 15033R, G64271, G64713, G64849, G65168, G71272, G71309, G65284, G72955, G65043, G70919, G72429, G72789, G70928, G72776, G72766, G63409, G63418, G64893, G66907, G65588, G65402, G73096, G73131, G71269, G71750, G71762, G71267, G71727, G71732, G71745, G71755, G71761, G66892, G65275, G70922, G73154, G64505, G65744, G73033, G73134, G64941, G63489, G65036, G64256, G72976, G73092, G73145, G64196, G64945, G72412, G73074, G65414, G71726, G71743, G64807, G66872, G67257, G40208, G64885, G38391, G39467, G39818, G65408, G70748, G37108, G6715, G67232, G71277, G71286, G64604, G37406, G40004, G63223, G63224, G63232, G61711, G71271, G71302, G72790, G64500, G65269, G65692, G65290, G65691, G66862, G65283, G64189, G70744, G64812, G70755, G65286, G65266, G72760, G66884, G64601, G71300, G67185, G63495, G64890, G72780, G64607, G63488, G63494, G71285 - NCR1161, G63501, G41245, G64797, G64819, G64855, G72803, G41213.

Distribution pattern

US: CA, IL, and NJ

device · product 37 of 46

Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system

Z-0278-2026
Recall number
Z-0278-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G39544, G62558, G71736, G40116, G65568, G65570.

Distribution pattern

US: CA, IL, and NJ

device · product 38 of 46

Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system

Z-0279-2026
Recall number
Z-0279-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G64274, G40012, G64597, G70742, G72764, G61804.

Distribution pattern

US: CA, IL, and NJ

device · product 39 of 46

Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system

Z-0280-2026
Recall number
Z-0280-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G38652, G37633, G36042, G37641, 608A, G36681.

Distribution pattern

US: CA, IL, and NJ

device · product 40 of 46

RADPRO MOBILE, Mobile X-ray system

Z-0281-2026
Recall number
Z-0281-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G30567, G31256, G32581, G30250, G28320, G30902, G29864, G35389, G30960, G33238, G31252, G33708, G30771, G33634, 31412, 31480, G33004, G33112, G33585, G31271, G31285, G32514, G32498, G35665.

Distribution pattern

US: CA, IL, and NJ

device · product 41 of 46

SED URS LP, Mobile X-ray system

Z-0282-2026
Recall number
Z-0282-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI unknown, Serial Numbers: 40116

Distribution pattern

US: CA, IL, and NJ

device · product 42 of 46

SHIMADZU RF.004, Mobile X-ray system

Z-0283-2026
Recall number
Z-0283-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI unknown, Serial Numbers: 75723

Distribution pattern

US: CA, IL, and NJ

device · product 43 of 46

SM_40HF_B_D_VIR3, Mobile X-ray system

Z-0284-2026
Recall number
Z-0284-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.

Distribution pattern

US: CA, IL, and NJ

device · product 44 of 46

SM_40HF_B_D_VIR3.004, Mobile X-ray system

Z-0285-2026
Recall number
Z-0285-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046002166, Serial Numbers: G73023, G87352, G80066.

Distribution pattern

US: CA, IL, and NJ

device · product 45 of 46

SM_40HF_BDC, Mobile X-ray system

Z-0286-2026
Recall number
Z-0286-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: 31526

Distribution pattern

US: CA, IL, and NJ

device · product 46 of 46

SM_40HF_BDC3, Mobile X-ray system

Z-0287-2026
Recall number
Z-0287-2026
Initiated
June 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Code information

UDI/DI 08436046001510, Serial Numbers: G41213

Distribution pattern

US: CA, IL, and NJ