Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97468

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

Open FDA event record

Event summary

Timeline bucket
August 13, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America Llc

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

10 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 10

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317

Z-2595-2025
Recall number
Z-2595-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
181 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728235; UDI-DI: N/A; Serial Numbers: 9223, 9115, 9225, 29144. 2. Model Number: 728231; UDI-DI: N/A; Serial Numbers: 95647, 9194, 95341, 95234, 10051, 95488, 10098, 95695, 10309, 95217, 95698, 10443, 10544, 10531, 10712, 10662, 95834, 9990, 9784, 95632, 9058, 9089, 9522, 9580, 9688, 9877, 9806, 9808, 9671, 9694, 9703, 9830, 29068, 9821, 9869, 9837, 90144, 95203, 95225, 95303, 95328, 95362, 95402, 95395, 9852, 95492, 95491, 9965, 9974, 95453, 95502, 10006, 10025, 95520, 10060, 95630, 95621, 10141, 95673, 10153, 10137, 95521, 90128, 9605, 10218, 10199, 10247, 10275, 10267, 10245, 10394, 10307, 90124, 10281, 95692, 29045, 95349, 95639, 10344, 10330, 10310, 10348, 10391, 10393, 10418, 10205, 9799, 10429, 29062, 10511, 10431, 10515, 10535, 10315, 10521, 10518, 10566, 10536, 10522, 10496, 10560, 10568, 90170, 10433, 10574, 10609, 10559, 10468, 95725, 10622, 95710, 95729, 10590, 10628, 10683, 10668, 10666, 10607, 95758, 10706, 95776, 95821, 95757, 95858, 95795, 9868, 10729, 95791, 10734, 10718, 95807, 10649, 95781, 95790, 95823, 95813, 10788, 10774, 95759, 95852, 95848, 95116, 95872, 95871, 95914, 95886, 95498, 95054, 95928, 95933, 95025, 90162, 95144, 29039, 95932, 95399, 10031, 90804, 10161, 10494, 9934, 90161. 3. Model Number: 728317; UDI-DI: N/A; Serial Numbers: 345040, 345053, 345155, 345031, 345048, 345056, 345055, 345063, 345050, 345100, 345117, 345122, 345133, 345131, 345171.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 2 of 10

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.

Z-2596-2025
Recall number
Z-2596-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
73 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728240; UDI-DI: N/A; Serial Number: 6022. 2. Model Number: 728246; UDI-DI: N/A; Serial Numbers: 5029, 5698, 5834, 6272, 6313, 5307, 5305, 50129, 5286, 50017, 5388, 5424, 5422, 5515, 5497, 5584, 5668, 5624, 5771, 5814, 5872, 5907, 5900, 5928, 5869, 5939, 5944, 5993, 6137, 5411, 6160, 6153, 5504, 6182, 6199, 6209, 6219, 6271, 6302, 6330, 6357, 6358, 6369, 6405, 6343, 6410, 6558, 6490, 6635, 6532, 6590, 6547, 6669, 6691, 6563, 6756, 6755, 6738, 3578, 6776, 260046, 260074, 6752, 50219, 50028, 5412, 5839. 3. Model Number: 728256; UDI-DI: N/A; Serial Numbers: 30117, 3290, 3347, 3664, 3499.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 3 of 10

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

Z-2597-2025
Recall number
Z-2597-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728242; UDI-DI: 00884838095168; Serial Number: 766018. 2. Model Number: 728243; UDI-DI: N/A; Serial Numbers: 7179, 7238, 7273, 7418, 7467, 7608, 7634, 7618, 7801, 7925, 75111, 75045, 75119, 75035, 75132, 750019, 76023. 3. Model Number: 728244; UDI-DI: 00884838059450; Serial Numbers: 7271, 7979, 76234, 750003, 7878, 76054, 760019, 76135, 76230, 76147, 76171, 760057, 760058, 76270, 760075.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 4 of 10

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

Z-2598-2025
Recall number
Z-2598-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
210 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728306; UDI-DI: 00884838059474; Serial Number: 100068, 100188, 100241, 100288, 100332, 100365, 100461, 85007, 85016, 100657, 100682, 100686, 100779, 100832, 100783, 100775, 100788, 100807, 100828, 100816, 85136, 85153, 100043, 100038, 100082, 100074, 100081, 100097, 100098, 100119, 100111, 100113, 100123, 100130, 100133, 100222, 100141, 100134, 100160, 100157, 100150, 100158, 100180, 100161, 100173, 100215, 100064, 100117, 100247, 100172, 100196, 200045, 100191, 100374, 100189, 100230, 100203, 100201, 100204, 100211, 100234, 100227, 100249, 100285, 100245, 100253, 100226, 100264, 100292, 100268, 100294, 100302, 100315, 100301, 100310, 100336, 100314, 100349, 100354, 100321, 100389, 100385, 100446, 100424, 100401, 100352, 100404, 100511, 100412, 100438, 100435, 100455, 100380, 100487, 100429, 100427, 100443, 100393, 100413, 100462, 100604, 100456, 100497, 100498, 100502, 100500, 100445, 100510, 100505, 100513, 100635, 85018, 85014, 100612, 85041, 100603, 85035, 85028, 100669, 100622, 100627, 85065, 100631, 100601, 100663, 85053, 100656, 85062, 100708, 100685, 85057, 85061, 100677, 100653, 100673, 100707, 100672, 100691, 100683, 100678, 100687, 100718, 100717, 85069, 100698, 100695, 100704, 100769, 85058, 100712, 100711, 100744, 100800, 100735, 100734, 100727, 100745, 100851, 100763, 100766, 100770, 85104, 100780, 100784, 85129, 100840, 100794, 100797, 100815, 100829, 85087, 100809, 85082, 100821, 100814, 100836, 100834, 100837, 100831, 85121, 85124, 85169, 85118, 85127, 85142, 85147, 85144, 85196, 85233, 85265, 85180, 85173, 85202, 87013, 85189, 85200, 85243, 85211, 85221, 85217, 85215, 85236, 87004, 85249, 85276, 87015, 87037, 87031, 87045, 87211.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 5 of 10

Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

Z-2599-2025
Recall number
Z-2599-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728311; UDI-DI: N/A; Serial Number: 200016, 200024, 200211, 200041, 200030, 200060, 200048, 200069, 200098, 200097, 200112, 200136, 200200, 200209.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 6 of 10

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.

Z-2600-2025
Recall number
Z-2600-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
285 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728321; UDI-DI: 00884838059498; Serial Numbers: 310033, 310095, 310098, 333020, 333135, 52084, 310005, 310019, 310030, 310038, 310050, 310057, 310053, 310075, 310126, 310009, 310101, 310108, 310157, 310170, 333024, 310171, 333061, 333021, 52007, 52017, 52039, 333053, 31001, 333130, 52025, 52037, 52056, 333132, 52063, 333077, 310288, 310230, 310221, 310238, 310294, 310286, 310233, 310259, 310283, 310293, 310262, 310274, 333092, 333107, 310317, 333131, 333118, 333124, 333151, 310326, 310323, 310340, 333153, 310356, 310382, 310378, 333166, 333179, 310397, 52103, 333193, 52121, 52122, 52157, 52161, 52153, 68106, 52194, 40009. 2. Model Number: 728323; UDI-DI: 00884838059504; Serial Numbers: 30016, 320084, 320099, 336069, 336118, 336107, 320271, 336237, 336769, 320439, 32291, 336447, 32358, 68164, 40085, 40075, 320008, 320037, 320019, 320017, 320071, 320042, 320055, 320101, 320108, 320104, 320117, 336056, 320122, 32058, 320129, 333019, 336030, 32016, 336028, 320070, 32003, 32004, 32014, 336070, 32010, 336033, 32089, 32072, 32048, 336067, 32076, 32061, 32046, 320233, 336076, 32094, 32001, 32065, 32130, 320322, 336708, 32084, 32105, 32103, 32096, 336704, 336130, 32118, 336108, 32143, 336115, 336129, 32135, 336109, 336113, 32136, 32137, 320251, 336735, 32028, 336114, 336158, 320258, 32163, 336175, 32149, 320284, 320270, 336784, 336767, 336762, 336770, 336177, 336754, 336768, 336774, 336781, 336246, 336758, 320278, 320356, 320363, 336772, 336259, 320281, 32169, 336785, 336797, 336783, 336796, 320313, 320304, 320300, 320315, 320311, 320327, 320314, 320346, 320365, 336801, 320320, 336266, 320368, 336286, 320353, 30035, 320352, 320376, 320379, 320382, 320397, 320375, 320409, 320422, 320420, 320417, 320424, 32180, 32177, 320432, 320494, 32207, 32185, 320450, 32188, 336354, 336355, 32205, 32211, 32216, 32231, 336396, 336387, 336403, 336423, 32283, 336391, 336433, 336437, 32323, 32346, 32330, 32339, 32338, 68116, 68131, 337000, 336492, 68159, 68155, 338034, 40030, 341006, 40038, 40044, 40063, 68187. 3. Model Number: 728326; UDI-DI: 00884838059511; Serial Numbers: 300017, 300163, 300209, 300251, 300019, 300045, 300039, 300090, 300089, 300096, 300097, 300133, 300114, 300203, 300148, 320103, 300160, 30013, 30006, 30007, 30026, 30034, 30029, 30045, 30031, 30043, 30044, 300239, 30046, 32045, 300228, 300236, 300231, 300230, 300238, 300249, 300259.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 7 of 10

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

Z-2601-2025
Recall number
Z-2601-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728332; UDI-DI: 00884838059542; Serial Numbers: 860088, 860023, 860077, 860086, 60019, 860152, 860215, 60031, 60123, 60129, 60152, 860011, 860049, 860019, 860008, 860030, 860025, 860009, 860022, 860013, 860024, 860020, 860036, 860041, 860046, 860055, 860058, 860054, 860073, 860065, 860070, 860072, 860066, 860103, 860076, 860085, 860095, 860102, 860101, 860104, 860175, 860136, 860117, 860120, 860121, 860124, 860125, 860191, 860131, 860150, 860164, 60041, 860207, 60003, 860157, 860167, 860158, 860196, 60012, 860176, 860185, 860168, 860179, 860194, 60010, 60013, 60007, 60001, 395003, 860209, 860208, 60036, 60030, 60027, 60054, 60055, 60053, 60058, 60079, 395005, 60145.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 8 of 10

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

Z-2602-2025
Recall number
Z-2602-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728324; UDI-DI: 00884838059863; Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090, 337116, 337136, 345016, 345032, 345099, 345104.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 9 of 10

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

Z-2603-2025
Recall number
Z-2603-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728325; UDI-DI: N/A; Serial Numbers: 338014, 338028, 338019.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

device · product 10 of 10

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

Z-2604-2025
Recall number
Z-2604-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information

1. Model Number: 728307; UDI-DI: 00884838104600; Serial Numbers: 87150, 87169, 87118, 87168, 87166, 87164.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.