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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91456

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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

6 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 6

GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3/8 inch NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 inch 16 SL, p) D670 DR 3/8 inch MEA, q) D670 DR 3/8 inch, r) D670 DR 3/8 inch 16SL, s) D670 DR 3/8 inch 16SL NR, t) D670 DR 3/8 inch BJ, u) D670 DR 3/8 inch MEA, v) D670 DR NM Gantry 3/8 inch, w) D670 DR NM Gantry 5/8 inch, x) D670 DR with new rotor, y) D670 ES NM Gantry 3/8 inch, z) D670 ES NM/CT 3/8 inch O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8 inch, bb) D670 GANTRY, cc) D670 PRO NM Gantry 3/8 inch, dd) D670 PRO NM GANTRY 3/8 inch, ee) DISC NM/CT670 DR 3/8 inch, ff) DISC NM/CT870 DR 3/8 inch, gg) DISC NM/CT870 DR 3/8 inch, hh) DISC NM/CT870 DR 5/8 inch, ii) DISCOVERY 670 (TANDEM), jj) DISCOVERY NM 670, kk) DISCOVERY NM/CT 670 3/8 inch PRO, ll) DISCOVERY NM/CT 670 3/8 inch PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS, nn) NM/CT 870 DR, oo) NM/CT 870 DR 3/8 inch CYBER DEFENCE, pp) NM/CT 870 DR 3/8 inch WSO, qq) NM/CT 870 DR O540 3/8 inch, rr) NM/CT 870 DR O540 3/8 inch BJ, ss) NM/CT 870 DR O540 5/8 inch, tt) NM/CT 870 ES 3/8 inch, uu) NM/CT 870DR China for China, vv) NM/CT870 DR 3/8 inch O540, ww) NM/CT D870 DR O540 3/8 inch, xx) TANDEM DISCOVERY 670 INT; Emission Computed Tomography System

Z-1053-2023
Recall number
Z-1053-2023
Initiated
December 19, 2022
Classification
Class I
Status
Ongoing
Quantity
557 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

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

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Code information

a) 870: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2200004, NT3DG2200009, NT3DG2200018, NT3DG2200002; b) 870 DR 3/8" NM GANTRY WITH NEW ROTOR - MEA: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2100018BH; c) 870 DR / Dismount: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100006; d) 870 DR / Dismount / 60HZ: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2000016BH; e) 870 DR 3/8" WSO: Catalog number H3906EM, UDI/DI Not Applicable, Serial Numbers: 870B64224, 870Z64148; f) 870 DR 3/8" NM Gantry: Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870Y64064, 870Y64040, 870A64172, 870Z64145, 870A64161, 870Z64111, 870Z64126, 870Y64081, 870A64210, 870X64003, 870A64180, 870Y64047, 870Y64044, 870Y64079, 870Y64050, 870Z64130, 870X64011, 870Y64095, 870Y64037, 870Y64074, 870Y64067, 870Y64051, 870A64162, 870X64024, 870A64163, 870A64165, 870X64002, 870Y64072, 870Z64107, 870Z64108, 870X64032, 870A64192, 870A64183, 870A64164, 870B64229, 870A64176, 870A64185, 870Z64137, 870Z64117, 870X64001, 870Y64055, 870Y64088, 870B64235, 870Y64078, 870Y64080, 870Z64125, 870Z64098, 870A64204, 870A64205, 870B64306, 870B64305, 870A64182, 870B64261, 870Y64069, 870Z64104, 870Y64042, 870Y64039, 870Y64086, 870Z64146, 870A64179, 870Y64085, 870A64168, 870Z64103, 870Y64094, 870Z64101, 870A64160, 870B64300, 870Y64046, 870B64302, 870A64199, 870Y64056, 870Z64121, 870A64174, 870X64004, 870X64012, 870X64007, 870Y64048, 870X64009, 870Z64124, 870X64026, 870Z64119, 870Z64122, 870Y64049, 870Y64089, 00000870Y64035, 870Z64134, 870Y64052, 870Y64076, 870Y64063, 870A64159, 870Z64133, 870B64286, 870B64247, 870B64244, 870A64184, 870B64240, 870B64264, 870B64287, 870A64196, 870A64187, 870B64307, 870A64208, 87EB77017, 870X64016, 870X64005, 870Z64136, 870Y64033, 870A64153, 870A64154, 870B64227, 870Y64091, 870B64231, 870B64292, 870Z64149, 87EA77011, 870X64022, 870Y64053, 870Z64114, 870Z64115, 87EZ77003, 87EB77016, 87EZ77004, 870B64233, 870Z64141, 87EB77014, 870A64175, 87EB77015, 870X64019, 870A64188, 870Y64059, 870Y64068, 870Y64071, 870Y64082, 870B64265, 870Z64102, 870X64020, 870Y64090, 870B64262, 870B64274, 870B64268, 870B64275, 870Z64128, 870B64270, 870B64271, 870B64272, 870B64273, 870B64266, 870B64280, 870B64267, 870Z64116, 870B64276, 870B64277, 870B64278, 870B64279, 870B64269, 870B64281, 870B64282, 870B64283, 870Z64142, 870Y64065, 870A64158, 870X64025, 87EZ77001, 870Z64120, 870Y64038, 870B64236, 870Y64077, 870A64202, 870A64207, 870B64251, 870B64221, 870A64197, 870X64010, 870Y64073, 870Y64036, 870Y64092, 870Y64087, 870X64027, 870X64029, 870Y64084, 870X64030, 870X64023, 870X64028, 87EA77010, 87EA77012, 870B64222, 870A64155, 870B64226, 870B64225, 87EB77018, 870B64297, 870B64299, 870B64293, 87EB77019, 870B64258, 870A64209, 87EZ77007, 870B64253, 870A64217, 870Z64127, 870B64285, 870Y64083, 870B64257, 870B64259, 870X64013, 870B64252, 870Z64105, 870Y64061, 870B64284, 870B64254, 870B64260, 870B64308, 870B64296, 870B64303, 870Z64110, 870Z64144, 870Y64075, 870A64171, 870A64215, 870A64212, 870Z64129, 870X64021, 870A64198, 870B64230, 870Z64113, 870Z64131, 870Z64132, 870Y64070, 870Z64140, 870B64263, 870B64294, 870A64190, 870Y64058, 870B64241, 870Z64135, 870Y64097, 870Z64099, 870Z64151, 870Y64057, 870A64157, 870B64242, 870B64243, 870B64250, 870Z64109, 870B64237, 870Z64106, 870A64173, 870X64008, 870A64152, 870B64218, 870B64234, 870B64238, 870B64239, 870A64200; g) 870 DR 3/8": Catalog number H3100AP, UDI/DI Not Applicable, Serial Numbers: 870Y64034; UDI/DI 010084068214083621870X6401511180900, Serial Numbers: 870X64015; h) 870 DR 3/8" CH: Catalog number H2402AG, UDI/DI To be provided, Serial Numbers: NT3DG1900005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1800002BH; i) 870 DR 5/8" NM GANTRY: Catalog number H3100Q, UDI/DI 010084068214083621870X6401811181000, Serial Numbers: 870X64017; UDI/DI 010084068214083621870Y6406611190700, Serial Numbers: 870Y64066; UDI/DI Not Applicable, Serial Numbers: 870Y64045, 870A64201, 00000870X64014, 870Y64041; j) 870 DR BJ / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG1900013BH; k) 870 DR CyberDefense 3/8" NM Gantry: Catalog number H3906FF, UDI/DI Not Applicable, Serial Numbers: 87CA83004, 87CA83001; , UDI/DI To be provided, Serial Numbers: 87CA83002, 87ZA83005; l) 870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870B64288, 00000870Z64139; m) 870 DR China: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100016BH; n) D670 NM GANTRY WITH NEW ROTOR: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870A64203, 87EA77013, 870B64255; o) D670 DR 3/8" 16 SL: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: DRGY56031, DRGY56025; UDI/DI Not Applicable, Serial Numbers: 00000DRGZ56044; Catalog number H3100BT, UDI/DI To be provided, Serial Numbers: 00000DRGX56017, 00000DRGZ56042; UDI/DI 010084068213935921DRGY5603011190700, Serial Numbers: DRGY56030; p) D670 DR 3/8" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG1900005BH; q) D670 DR 3/8": Catalog number H3100AK, UDI/DI Not Applicable, Serial Numbers: 00000589470GE4; r) D670 DR 3/8" 16SL: Catalog number 5791566, UDI/DI Not Applicable, Serial Numbers: DRGY56024; Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGY56026, DRGX56023, DRGX56009, DRGZ56047, DRGZ56049, DRGZ56045, DRGZ56051, DRGZ56056, DRGZ56046; s) D670 DR 3/8" 16SL NR: Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGZ56050; t) D670 DR 3/8" BJ: Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1800002BH, UDI/DI 01008406821393111119030021NT2RG1900001BH, Serial Numbers: NT2RG1900001BH; u) D670 DR 3/8" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG2200001BH; v) D670 DR NM Gantry 3/8": Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGX56002, DRGY56028, DRGX56005, DRGY56033, DRGX56004, DRGY56037, DRGX56003, DRGX56008, DRGX56007, DRGY56033, DRGZ56039, DRGX56011, DRGX56006, DRGX56021, DRGZ56054, DRGZ56040, DRGY56038, DRGY56032, DRGX56019, DRGZ56052, DRGX56012, DRGY56029, DRGY56027, DRGZ56048, DRGX56014, DRGZ56053, DRGZ56055, DRGY56034, DRGX56020, DRGX56016, DRGY56036, DRGX56022, DRGX56015, DRGZ56041; UDI/DI To be provided, Serial Numbers: DRGX56018, DRGA56057, DRGA56058; UDI/DI 010084068213935921DRGY5603511190900, Serial Numbers: DRGY56035; UDI/DI 010084068213935921DRGZ5604311200400, Serial Numbers: DRGZ56043; w) D670 DR NM Gantry 5/8": Catalog number H3100CM, UDI/DI Not Applicable, Serial Numbers: DRGX56010; x) D670 DR with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2RG1900003, NT2RG2000001BH; y) D670 ES NM Gantry 3/8": Catalog number H3100XF, UDI/DI Not Applicable, Serial Numbers: ESGY53002, ESGY53001, ESGY53003, ESGZ53005, ESGA53008, ESGB53011, ESGZ53004, ESGA53007, ESGZ53006, ESGA53010, ESGA53009; z) D670 ES NM/CT 3/8" O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8": Catalog number H3100BM, UDI/DI Not Applicable, Serial Numbers: ESPX54001, ESPY54002; bb) D670 GANTRY: Catalog number H3100BM , UDI/DI Not Applicable, Serial Numbers: ESPY54003; cc) D670 PRO NM Gantry 3/8": Catalog number H3100NC, UDI/DI UDI Not Required, Serial Numbers: 21128; dd) D670 PRO NM GANTRY 3/8": Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52045, PRGY52027, PRGA52061, PRGY52021, PRGY52023, PRGY52018, PRGZ52057, PRGY52013, PRGZ52048, PRGY52020, PRGZ52058, PRGX52008, PRGZ52046, PRGA52063, PRGA52068, PRGX52007, PRGZ52047, PRGZ52059, PRGA52066, PRGA52070, PRGY52039, PRGY52012, PRGZ52051, PRGX52004, PRGZ52055, PRGY52016, PRGX52009, PRGY52015, PRGZ52054, PRGY52031, PRGY52036, PRGY52024, PRGY52028, PRGY52025, PRGY52037, PRGY52032, PRGY52029, PRGZ52050, PRGX52005, PRGA52064, PRGY52030, PRGZ52056, PRGA52069, PRGX52002, PRGX52006, PRGX52003, PRGA52060; , UDI/DI UDI_Not_Required_2, Serial Numbers: PRGY52035; , UDI/DI To be provided, Serial Numbers: PRGA52077, PRGA52072, PRGA52073, PRGA52075, PRGB52083, PRGA52076, PRGA52079, PRGB52080, PRGB52081, PRGB52082, PRGA52071, PRGA52074, PRGB52084, PRGA52078; UDI/DI 010084068213937321PRGX5200111180700, Serial Numbers: PRGX52001; UDI/DI 010084068213937321PRGX5201011181200, Serial Numbers: PRGX52010; UDI/DI 010084068213937321PRGY5201111190100, Serial Numbers: PRGY52011; UDI/DI 010084068213937321PRGY5201711190300, Serial Numbers: PRGY52017; ee) DISC NM/CT670 DR 3/8": Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1900002BH; UDI/DI To be provided, Serial Numbers: T2RG1900004BH; ff) DISC NM/CT870 DR 3/8": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EA77009, 870A64177, 870A64156, 870Y64043, 870Z64112, 870Z64150; UDI/DI UDI Not Required, Serial Numbers: 870Y64096; UDI/DI To be provided, Serial Numbers: 870B64304, 00000870Z64147, 870Y64093, 870B64245; gg) DISC NM/CT870 DR 5/8": Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870X64018; hh) DISCOVERY 670 (TANDEM): Catalog number H3100XB , UDI/DI To be provided , Serial Numbers: PRGZ52040; ii) DISCOVERY NM 670: Catalog number 5474053, UDI/DI To be provided, Serial Numbers: 27053; kk) DISCOVERY NM/CT 670 3/8" PRO: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52044, PRGA52065, PRGY52033, PRGZ52041, PRGZ52043, PRGZ52052, PRGY52026, PRGY52022, PRGY52014, PRGA52067, PRGY52034, PRGA52062; UDI/DI UDI_Not_Required_2, Serial Numbers: PRGZ52049, PRGZ52042; UDI/DI To be provided, Serial Numbers: PRGY52019; ll) DISCOVERY NM/CT 670 3/8" PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 00000870Y64060; nn) NM/CT 870 DR: Catalog number H3100AS , UDI/DI To be provided, Serial Numbers: 87EZ77008; oo) NM/CT 870 DR 3/8" CYBER DEFENCE: Catalog number H3906FF, UDI/DI To be provided, Serial Numbers: 87ZB83006, 87CA83003; pp) NM/CT 870 DR 3/8" WSO: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870A64189, 870A64216, 870B64228, 870B64220, 870B64223, 870A64181, 870A64211, 870A64213, 870B64249; Catalog number 5376204-70-60, UDI/DI 010084068214083621870A6421411211100, Serial Numbers: 870A64214; UDI/DI 010084068214083621870A6419511210900, Serial Numbers: 870A64195; UDI/DI 010084068214083621870A6419411210800, Serial Numbers: 870A64194; UDI/DI 010084068214083621870B6425611220500, Serial Numbers: 870B64256; UDI/DI 010084068214083621870A6419311210800, Serial Numbers: 870A64193; UDI/DI 010084068214083621870B6423211220200, Serial Numbers: 870B64232; UDI/DI 010084068214083621870B6424611220300, Serial Numbers: 870B64246; UDI/DI 010084068214083621870B6424811220300, Serial Numbers: 870B64248; UDI/DI 010084068214083621870A6419111210800, Serial Numbers: 870A64191; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870B64295; qq)NM/CT 870 DR O540 3/8": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900012BH, NT3DG2000001BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200013BH; Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870X64031, 87EZ77006, 87EZ77005, 870Z64143, 870Y64062, 870Z64123, 870Z64118, 870A64169, 870A64166; : Catalog number To be provided, UDI/DI 010084068214083621870B6429111221100, Serial Numbers: 870B64291; Catalog number To be provided, UDI/DI 010084068214083621870B6430111221100, Serial Numbers: 870B64301; rr) NM/CT 870 DR O540 3/8" BJ: Catalog number 5376204-70-60-1, UDI/DI 01008406821421201121050621NT3DG2100005BH, Serial Numbers: NT3DG2100005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1900014BH, NT3DG1900015BH, NT3DG2100010BH, NT3DG2100007BH, NT3DG2200005BH, NT3DG1900002BH, NT3DG2100011BH, NT3DG2200003BH, NT3DG2200014BH, NT3DG2000012BH, NT3DG1900001BH, NT3DG1800001BH, NT3DG2100003BH, NT3DG2200007BH, NT3DG2100001BH, NT3DG2100012BH, NT3DG2100008BH; UDI/DI To be provided, Serial Numbers: NT3DG1900009BH, NT3DG2200004BH, NT3DG2000013BH, NT3DG1900006BH, NT3DG2100002BH, NT3DG1900004BH, NT3DG1900011BH, NT3DG2100013BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200019BH, NT3DG2000003BH, NT3DG2000005BH, NT3DG2000006BH; : Catalog number To be provided, UDI/DI Not Applicable , Serial Numbers: NT3DG2000004BH, NT3DG2200011BH, NT3DG2200017BH, NT3DG2000014BH; ss) NM/CT 870 DR O540 5/8": Catalog number H3100Q, UDI/DI Not Applicable, Serial Numbers: 870A64170; Catalog number 5791566, UDI/DI Not Applicable , Serial Numbers: 870Z64138, 870B64219; tt) NM/CT 870 ES 3/8": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EZ77002; uu) NM/CT 870DR China for China: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200010BH; NT3DG2200015BH, NT3DG2100015BH, NT3DG2200006BH, NT3DG2200001BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200016BH, NT3DG2200012BH; vv) NM/CT 870 DR 3/8" O540: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2000008BH, NT3DG2000010BH, NT3DG2000011BH, NT3DG2100009BH, NT3DG2100014BH, NT3DG2100004BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200008BH ww) NM/CT D870 DR O540 3/8": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900010BH, NT3DG1900003BH, NT3DG2000015BH; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2000002BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870A64186; xx) TANDEM DISCOVERY 670 INT: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGY52038.

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

device · product 2 of 6

GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 X 3/8 inch. Emission Computed Tomography System

Z-1054-2023
Recall number
Z-1054-2023
Initiated
December 19, 2022
Classification
Class I
Status
Ongoing
Quantity
748 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

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

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Code information

a) 830: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200003, NT3AG2000015BH, NT3AG2100015BH, NT3AG2200006BH; b) 830 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial numbers: NT3AG2100016BH; c) 830 /: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100009BH; d) 830 / 5842894-20: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200013; e) 830 / Dismount / 50HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2000017BH; f) 830 / Dismount / 60HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100001; g) 830 3/8 inch Detector: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60105; h) 830 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900009BH; Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG1900015BH; i) 830 BJ / 5144407: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900008BH; j) 830 BJ / Dismount: Catalog number 5376204-32-1, UDI/DI To be provided, Serial Numbers: NT3AG1900016BH; k) 830 ES DEM: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 83EZ88002, 830Z60256; l) 830 NM Cyber Defense Configuration Gantry 3/8 inch: Catalog number H3910AG, UDI/DI Not Applicable, Serial Numbers: 830Z60185, 830Z60224, 830Z60225; m) 830 NM Gantry 3/8 inch: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60050, 830Z60199, 830A60284, 830A60290, 830X60001, 830X60004, 830Y60056, 830Y60069, 830Z60158, 830Z60182, 83EA88010, 830Z60183, 830A60282, 830Z60192, 830A60271, 830Y60122, 830A60298, 830A60289, 830Y60048, 830Y60036, 830Z60239, 830A60294, 830Y60046, 830X60012, 830Y60054, 830Z60269, 830X60018, 830A60283, 830Y60089, 830Y60096, 830Z60165, 830Z60169, 830Y60051, 830Z60244, 830A60288, 830X60026, 830Y60030, 830Z60197, 830Z60227, 830A60277, 830A60334, 830Y60079, 830Y60131, 830Y60141, 83EA88008, 830Z60238, 830Z60207, 830Z60248, 830Y60137, 830Z60149, 830Z60175, 830Y60076, 830Y60092, 830Y60090, 830A60301, 830A60279, 830Z60178, 830Z60153, 830Y60132, 830X60011, 830X60016, 830Y60102, 830Z60253, 830Z60264, 830Y60049, 830Z60265, 830Z60254, 830Y60081, 830Z60263, 830Z60200, 830A60308, 830A60300, 830Z60171, 830Y60057, 830Y60029, 830Y60106, 830Y60059, 830Z60177, 830A60291, 830Z60267, 830Z60174, 830Z60245, 830Y60074, 830Z60167, 830Y60071, 830Z60246, 830Z60223, 830Z60201, 830Y60045, 830X60019, 83EZ88001, 830Y60124, 830A60306, 830A60297, 830Z60213, 830Y60111, 830Y60127, 830Y60094, 830Z60258, 830Y60058, 830Z60218, 830Y60138, 830A60280, 830A60274, 830Z60211, 830Y60101, 830Z60210, 830Z60260, 830Z60234, 830Y60118, 830X60027, 830Z60228, 830Z60168, 830Z60214, 830Y60044, 830Y60053, 830Z60173, 830Z60195, 830Y60123, 830Y60117, 830Y60129, 830Z60148, 830X60023, 830X60006, 830Y60104, 830X60015, 830Y60121, 830A60281, 830Y60133, 830Y60098, 830Z60268, 830Z60194, 830Z60198, 830X60014, 830Y60040, 830X60003, 830Z60159, 830Z60237, 830Y60060, 830A60278, 83EA88006, 830Z60222, 830Z60250, 830Z60181, 830Y60134, 830Z60152, 830Z60202, 830Z60220, 830Z60230, 830Y60062, 830Y60097, 830Z60176, 830Z60196, 830Y60125, 830X60025, 830A60293, 830A60307, 830Z60249, 830Z60180, 830Y60064, 830Y60078, 830Y60115, 830Y60114, 830Y60043, 830Y60108, 830A60275, 830Y60130, 830Z60229, 830A60292, 830Z60163, 830Y60128, 830X60021, 830Z60266, 830Y60100, 830A60304, 830Y60099, 830Y60034, 830Y60087, 830X60028, 830Y60084, 830Y60055, 830Y60136, 830Z60188, 830Z60206, 830Z60151, 830X60017, 830Y60140, 83EA88009, 830Z60154, 830Y60112, 830A60276, 830Y60082, 830Y60093, 830A60305, 830Z60232, 830Y60066, 830Z60191, 830Z60236, 830A60285, 830Z60235, 830Z60157, 830Y60126, 830Y60142, 830Y60035, 83EA88007, 830A60286, 830Y60107, 830Y60080, 830X60002, 830Z60270, 830Y60067, 830Z60193, 830Z60172, 830X60022, 830Y60095, 830Y60119, 830Y60042, 830Z60156, 830X60024, 830B60457, 830Y60047, 830Z60205, 830X60013, 830Y60073, 830Y60032, 830A60310, 830Z60219, NT3AG1900017BH, 830Z60257, 830Z60247, 830Z60240, 830Z60203, 830Y60085, 830Y60077, 830Z60255, 830A60311, 830Y60033, 830X60020, 830A60287, 830Y60038, 83EZ88004, 83EZ88005, 830X60010, 830Z60252, 830Z60166, 830Y60061, 830Y60091, 830Z60184, 830A60309, 830Z60217, 830Z60155, 830X60005, 830X60008, 830X60009, 830Y60052, 830Y60063, 830Y60143, 830Y60144, 830Y60146, 830Z60231, 830Z60187, 830A60296, 830Y60041, 830Y60088, 830Z60226, 830Z60262, 830X60007, 830Z60259, 830Z60212, 830Y60065, 830Y60135, 830Z60204, 830Y60072, 830Z60160; UDI/DI UDI_Not_Required_2, Serial Numbers: 830Y60113; , UDI/DI UDI_Not_Required_6, Serial Numbers: 830A60299; UDI/DI 010084068214082921830A6032811210700, Serial Numbers: 830A60328; UDI/DI 010084068214082921830Z6015011200100, Serial Numbers: 830Z60150; UDI/DI 010084068214082921830A6027211210100, Serial Numbers: 830A60272; UDI/DI 010084068214082921830B6042411220500, Serial Numbers: 830B60424; UDI/DI 010084068214082921830Z6019011200400, Serial Numbers: 830Z60190; UDI/DI 010084068214082921830A6027311210100, Serial Numbers: 830A60273; UDI/DI 010084068214082921830Z6018911200400, Serial Numbers: 830Z60189; UDI/DI 010084068214082921830Y6007511190600, Serial Numbers: 830Y60075; UDI/DI (01)00840682140829(21)830B60400(11)220200, Serial Numbers: 830B60400; UDI/DI 010084068214082921830Z6017011200200, Serial Numbers: 830Z60170; UDI/DI (01)00840682140829(21)830A60346(11)211100, Serial Numbers: 830A60346; UDI/DI 010084068214082921830Y6010311190900, Serial Numbers: 830Y60103; UDI/DI 010084068214082921830Y6014511191200, Serial Numbers: 830Y60145; UDI/DI 010084068214082921830A6030311210500, Serial Numbers: 830A60303; UDI/DI (01)00840682140829(21)830A60345(11)211000, Serial Numbers: 830A60345; UDI/DI 010084068214082921830A6029511210300, Serial Numbers: 830A60295; UDI/DI 010084068214082921830Z6023311200900, Serial Numbers: 830Z60233; UDI/DI 010084068214082921830Z6020911200600, Serial Numbers: 830Z60209; UDI/DI (01)00840682140829(21)830B60386(11)220100, Serial Numbers: 830B60386; UDI/DI (01)00840682140829(21)830B60434(11)220600, Serial Numbers: 830B60434; UDI/DI 010084068214082921830Y6010911191000, Serial Numbers: 830Y60109; UDI/DI 010084068214082921830Z6016211200200, Serial Numbers: 830Z60162; UDI/DI 010084068214082921830Z6017911200300, Serial Numbers: 830Z60179; UDI/DI 010084068214082921830Z6018611200300, Serial Numbers: 830Z60186; UDI/DI 010084068214082921830B6042711220500, Serial Numbers: 830B60427; UDI/DI 010084068214082921830A6037811211200, Serial Numbers: 830A60378; , UDI/DI To be provided, Serial Numbers: 830B60383, 830A60337, 830A60373, 830A60368, 830B60387, 830B60458, 830B60459, 830B60460, 830B60462, 830B60464, 830B60465, 830B60466, 830B60421, 830B60430, 830B60443, 830B60456, 830B60473, 830B60384, 83EB88026, 83EA88017, 830A60317, 830B60401, 830B60432, 830B60422, 830B60467, 830B60471, 830B60398, 830A60364, 83EB88027, 83EB88028, 830A60326, 830B60411, 830B60469, 830B60472, 830B60389, 830A60333, 830A60347, 830A60348, 830B60447, 830A60313, 830A60375, 830A60374, 830B60412, 830A60339, 830B60461, 830B60463, 830B60470, 830A60365, 830B60446, 830B60397, 83EB88034, 83EB88025, 83EA88011, 830B60431, 830B60428, 830B60416, 830B60441, 830A60363; n) 830 NM Gantry 5/8 inch: Catalog number H3910AD, UDI/DI To be provided, Serial Numbers: 830B60468, 830B60379; o) 870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2000009BH; p) B615 to D630 UPG: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT2UG2100001; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2UG2100002; q) D630 NM GANTRY: Catalog number H3100JY, UDI/DI 01008406821392742163GX5002611180700, Serial Numbers: 63GX50026; Catalog number H3100JY, UDI/DI Not Applicable, Serial Numbers: 0000063GX50023; r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA: Catalog number 5376204-31-1, UDI/DI To be provided, Serial Numbers: NT2PG2000001BH; s) D630 NM Gantry 3/8 inch: Catalog number H3101RH, UDI/DI Not Applicable, Serial Numbers: 63GY50074, 63GX50024, 63GZ50134, 63GY50110, 63GY50119, 63GY50067, 63GY50123, 63GX50001, 63GX50037, 63GX50060, 63GY50089, 63GY50087, 63GY50098, 63GY50097, 63GX50034, 63GZ50152, 63GY50094, 63GY50128, 63GY50131, 63GX50014, 63GY50079, 63GY50130, 63GY50101, 63GZ50147, 63GZ50136, 63GX50019, 63GZ50150, 63GZ50141, 63GY50078, 63GX50022, 63GX50021, 63GX50031, 63GX50018, 63GY50082, 63GX50009, 63GY50080, 63GY50118, 63GZ50133, 63GY50077, 63GX50043, 63GY50116, 63GX50020, 63GX50054, 63GX50008, 63GX50035, 63GX50050, 63GX50061, 63GX50062, 63GY50085, 63GZ50151, 63GY50125, 63GY50102, 63GX50032, 63GX50055, 63GY50090, 63GX50013, 63GX50047, 63GX50002, 63GX50025, 63GX50033, 63GX50038, 63GY50115, 63GX50044, 63GY50129, 63GY50120, 63GY50068, 63GX50063, 63GY50104, 63GY50069, 63GX50016, 63GY50075, 63GX50017, 63GX50005, 63GY50084, 63GX50029, 63GZ50135, 63GX50012, 63GY50127, 63GY50124, 63GX50046, 63GZ50148, 63GX50039, 63GX50049, 63GY50083, 63GX50011, 63GX50030, 63GY50108, 63GY50103, 63GY50113, 63GY50114, 63GZ50146, 63GX50057, 63GZ50145, 63GA50153, 63GZ50149, 63GY50100, 63GZ50142, 63GX50045, 63GA50155, 63GA50154, 63GY50111, 63GY50112, 0000063GX50048, 63GX50040, 63GX50003, 63GX50065, 63GZ50137, 63GY50107, 63GZ50138, 63GX50042, 63GY50088, 63GY50126, 63GX50053, 63GX50004, 63GY50086, 63GZ50132, 63GX50056, 63GX50066, 63GX50059;UDI/DI 01008406821392742163GY5007611190200, Serial Numbers: 63GY50076; UDI/DI 01008406821392742163GX5005111181000, Serial Numbers: 63GX50051; UDI/DI 01008406821392742163GX5005211181000, Serial Numbers: 63GX50052; UDI/DI 01008406821392742163GY5007011190100, Serial Numbers: 63GY50070; UDI/DI 01008406821392742163GY5009511190400, Serial Numbers: 63GY50095; UDI/DI 01008406821392742163GY5012111191100, Serial Numbers: 63GY50121; UDI/DI 01008406821392742163GX5002711180700, Serial Numbers: 63GX50027; UDI/DI 01008406821392742163GX5003611180700, Serial Numbers: 0000063GX50036; UDI/DI 01008406821392742163GY5009611190400, Serial Numbers: 63GY50096; UDI/DI 01008406821392742163GX5000711180500, Serial Numbers: 63GX50007; UDI/DI 01008406821392742163GX5000611180500, Serial Numbers: 63GX50006; UDI/DI 01008406821392742163GX5001011180600, Serial Numbers: 63GX50010; UDI/DI 01008406821392742163GX5001511180600, Serial Numbers: 63GX50015; UDI/DI 01008406821392742163GY5011711190900, Serial Numbers: 63GY50117; UDI/DI 01008406821392742163GY5007111190100, Serial Numbers: 63GY50071; UDI/DI 01008406821392742163GY5007211190100, Serial Numbers: 63GY50072; UDI/DI (01)00840682139274(21)63GY50106(11)190700, Serial Numbers: 63GY50106; UDI/DI 01008406821392742163GY5007311190100, Serial Numbers: 63GY50073; UDI/DI To be provided, Serial Numbers: 63GX50041, 63GY50105, 63GA50161, 63GB50165, 63GA50162, 63GA50157, 63GA50159, 63GA50160, 63GA50156, 63GA50163, 63GB50166; t) D630 NM GANTRY FINAL ASSEMBLY, : Catalog number 5791570, UDI/DI To be provided, Serial Numbers: 830B60423, 830B60429; u) D630 with new rotor: Catalog number H2405AC, UDI/DI To be provided, Serial Numbers: NT2PG1900006, NT2PG1900005; v) D630 with new rotor/ 5144407 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2PG1900007BH; w) D630 with new rotor/ Dismount: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1800001BH; x) DISCOVERY D630 X3/8 inch: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1900009BH, NT2PG1900008BH; y) DISCOVERY D630X 3/8 inch: Catalog number 5791570, UDI/DI Not Applicable, Serial Numbers: 0000063GZ50139; z) DISCOVERY D630X3/8 inch: Catalog number H3101RH, UDI/DI 01008406821392742163GY5009111190400, Serial Numbers: 63GY50091; UDI/DI Not Applicable, Serial Numbers: 63GY50093, 63GY50099, 63GZ50144, 63GZ50140, 63GY50122, 63GY50092, 63GB50164, 63GX50064, 63GX50028, 63GX50058, 63GY50081, 63GY50109, 63GZ50143; aa) DISCOVERY D630x3/8 inch BHW: Catalog number H2405AC, UDI/DI 01008406821393281119060021NT2PG1900010BH, Serial Numbers: NT2PG1900010BH; bb) DISCOVERY D630X3/8 inch BJG: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1900004BH, NT2PG1900001BH, NT2PG1900002BH, NT2PG1900012BH; cc) DISCOVERY D630X3/8 inch MEA: Catalog number 5376204-31-1, UDI/DI 01008406821393281119100021NT2PG1900011BH, Serial Numbers: NT2PG1900011BH; dd) DISCOVERY NM 830 3/8 inch: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2200012BH; UDI/DI To be provided, Serial Numbers: NT3AG2100004BH, NT3AG2200007BH; UDI/DI Not Applicable, Serial Numbers: NT3AG2200012BH; ee) DISCOVERY NM 830 3/8 inch: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60110, 830Z60164; ff) NM 830 3/8 inch: Catalog number 5791570, UDI/DI To be provided, Serial Numbers: 830A60336, 830Y60031; Catalog number 5376204-31-1, UDI/DI To be provided, Serial Numbers: NT3AG2000005BH; Catalog number 5376204-32, UDI/DI 010084068214082921830A6035511211100, Serial Numbers: 830A60355; UDI/DI 010084068214082921830A6032511210700, Serial Numbers: 830A60325; UDI/DI 010084068214082921830A6037111211200, Serial Numbers: 830A60371; UDI/DI 010084068214082921830B6040911220300, Serial Numbers: 830B60409; UDI/DI 010084068214082921830B6043911220700, Serial Numbers: 830B60439; UDI/DI 010084068214082921830B6041411220400, Serial Numbers: 830B60414; UDI/DI 010084068214082921830A6032411210700, Serial Numbers: 830A60324; UDI/DI 010084068214082921830B6041511220400, Serial Numbers: 830B60415; UDI/DI 010084068214082921830B6043311220600, Serial Numbers: 830B60433; UDI/DI 010084068214082921830A6032911210800, Serial Numbers: 830A60329; UDI/DI 010084068214082921830B6044211220700, Serial Numbers: 830B60442; UDI/DI 01008406821408292183EB8803111220700, Serial Numbers: 83EB88031; UDI/DI 010084068214082921830B6044411220700, Serial Numbers: 830B60444; UDI/DI 010084068214082921830A6034411211000, Serial Numbers: 830A60344; UDI/DI 010084068214082921830B6040411220300, Serial Numbers: 830B60404; UDI/DI 010084068214082921830A6033211210800, Serial Numbers: 830A60332; UDI/DI 010084068214082921830A6032311210700, Serial Numbers: 830A60323; UDI/DI 010084068214082921830B6040211220200, Serial Numbers: 830B60402; UDI/DI 010084068214082921830A6035211211100, Serial Numbers: 830A60352; UDI/DI 010084068214082921830B6044811221000, Serial Numbers: 830B60448; UDI/DI 010084068214082921830A6031511210600, Serial Numbers: 830A60315; UDI/DI 010084068214082921830A6031811210600, Serial Numbers: 830A60318; UDI/DI 010084068214082921830B6042511220500, Serial Numbers: 830B60425; UDI/DI 010084068214082921830A6031911210600, Serial Numbers: 830A60319; UDI/DI 010084068214082921830A6036611211200, Serial Numbers: 830A60366; Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60147, 830B60455, 830Z60261, 830Z60221, 830Z60215, 830Y60070, 830Y60083, 830Y60037, 830Z60161, 830Y60039, 830A60302, 830Z60216, 830Z60242, 830Z60241, 830Z60251, 830Y60086, 830Z60243, 830Z60208; UDI/DI UDI_Not_Required_2, Serial Numbers: 830Y60116; UDI/DI To be provided, Serial Numbers: 830A60356, 830B60449, 830A60350, 83EB88032, 830A60322, 830B60445, 830B60435, 830A60358, 830B60408, 830A60349, 830B60453, 830A60357, 830A60335, 830B60410, 830B60395, 830A60354, 830B60385, 830A60331, 830B60396, 830A60360, 830B60381, 830B60406, 830B60403, 830A60320, 830A60321, 830B60426, 830B60388, 830A60369, 830B60399, 830B60419, 830A60377, 830A60316, 830B60382, 830B60452, 830A60370, 830A60376, 830B60413, 830A60314, 830A60367, 830B60394, 830B60436, 830A60342, 830A60362, 830B60440, 830B60407, 830A60312, 830B60380, 830B60418, 830A60353, 830A60330, 830B60390, 830A60372, 830A60359, 830A60341, 830A60338, 830A60327, 830B60405, 830A60361, 830B60454, 830A60340, 830A60351; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 830B60437, 830B60393, 830B60420, 830B60438, 830A60343; gg) NM 830 3/8 inch BJ: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2200001BH, NT3AG2100007BH, NT3AG2100003BH, NT3AG2000008BH, NT3AG2000002BH, NT3AG2200010BH, NT3AG1900002BH , NT3AG2200009BH, NT3AG1900014BH, NT3AG1900012BH, NT3AG2000006BH, NT3AG2100008BH, NT3AG2000013BH, NT3AG2100010BH, NT3AG2200005BH, NT3AG1900011BH, NT3AG2000016BH, NT3AG2100002BH, NT3AG2200011BH, NT3AG2100011BH, NT3AG1900018BH, NT3AG2000001BH, NT3AG1900003BH, NT3AG1900001BH, NT3AG1800001BH, NT3AG2100014BH, NT3AG1900010BH, NT3AG2000003BH, NT3AG2000012BH, NT3AG1900006BH, NT3AG2100005BH, NT3AG2000011BH, NT3AG2200008BH, NT3AG1800002BH, NT3AG2000010BH; UDI/DI To be provided, Serial Numbers: NT3AG2200014BH, NT3AG1900013BH, NT3AG2200002BH, NT3AG2100012BH, NT3AG2100013BH; Catalog number H2406AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1800003BH, NT3AG1900004BH, NT3AG2200016, NT3AG2200015BH; Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 83EZ88003; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200004BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3AG1900005BH, NT3AG2000004BH; hh) NM 830 ES: Catalog number 5376204-32, UDI/DI 01008406821408292183EA8801811211000, Serial Numbers: 83EA88018; UDI/DI 01008406821408292183EA8801411210800, Serial Numbers: 83EA88014; UDI/DI 01008406821408292183EB8801911220100, Serial Numbers: 83EB88019; UDI/DI 01008406821408292183EB8802311220200, Serial Numbers: 83EB88023; UDI/DI 01008406821408292183EB8803011220500, Serial Numbers: 83EB88030; UDI/DI 01008406821408292183EA8801211210600, Serial Numbers: 83EA88012; UDI/DI 01008406821408292183EA8801511210900, Serial Numbers: 83EA88015; UDI/DI 01008406821408292183EA8801311210800, Serial Numbers: 83EA88013; UDI/DI 01008406821408292183EB8802411220200, Serial Numbers: 83EB88024; Catalog number H3910AC, UDI/DI To be provided, Serial Numbers: 83EB88029, 83EB88022, 83EA88016; UDI/DI Not Applicable, Serial Numbers: 83EB88021; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 83EB88020; ii) NM DISCOVERY D630 3/8 inch: Catalog number 5474054, UDI/DI To be provided, Serial Numbers: 22404; jj) NUC GOLDSEAL D630X3/8 inch: Catalog number S9630NU, UDI/DI Not Applicable, Serial Numbers: NT2QG1900003BH.

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

device · product 3 of 6

GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

Z-1055-2023
Recall number
Z-1055-2023
Initiated
December 19, 2022
Classification
Class I
Status
Ongoing
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

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

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Code information

a) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1900001BH; b) BRIVO 615 3/8 inch: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG2000002BH; c) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG2000001BH; d) B615 with new rotor: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG1900002BH; e) BRIVO B615 3/8 inch BJG: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1800001BH; f) BRIVO B615 3/8 inch DHP BJG NR: Catalog number H2402MP, UDI/DI To be provided, Serial Numbers: 00000168527HL0; g) B615 with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2QG2000003BH;

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

device · product 4 of 6

GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

Z-1056-2023
Recall number
Z-1056-2023
Initiated
December 19, 2022
Classification
Class I
Status
Ongoing
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

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

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Code information

a) OPTIMA O640X3/8 inch NR: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51002, 64GY51003, 64GY51004, 0000064GY51011, 64GY51005; b) DISCOVERY O640X 3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GY51021; c) NM OPTIMA O640X3/8 inch: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 26043; d) O640 NM Gantry 3/8 inch: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51022; , UDI/DI Not Applicable, Serial Numbers: 64GY51024, 64GY51007, 64GY51019, 64GY51018, 64GY51016, 64GX51001, 64GY51006, 64GY51013, 64GZ51026, 64GY51025, 64GY51012, 64GY51023, 64GY51014, 64GZ51027; UDI/DI To be provided, Serial Numbers: 64GY51008, 64GY51009, 64GY51020, 64GZ51028, 64GZ51030, 64GY51015, 64GY51011; e) O640 NM GANTRY FINAL ASSY: Catalog number H3100JZ, UDI/DI To be provided, Serial Numbers: ONMX26515; f) OPTIMA O640X3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GZ51029, 64GZ51031; Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51017; UDI/DI To be provided, Serial Numbers: 64GY51010.

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

device · product 5 of 6

GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

Z-1057-2023
Recall number
Z-1057-2023
Initiated
December 19, 2022
Classification
Class I
Status
Ongoing
Quantity
86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

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

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Code information

a) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW , UDI/DI 01008406821408432187CZ6304211200300, Serial Numbers: 87CZ63042; UDI/DI 01008406821408432187CA6305311210100, Serial Numbers: 87CA63053; UDI/DI 01008406821408432187CX6301111181000, Serial Numbers: 87CX63011; UDI/DI 01008406821408432187CY6302011190300, Serial Numbers: 87CY63020; UDI/DI 01008406821408432187CY6303511191100, Serial Numbers: 87CY63035; UDI/DI 01008406821408432187CZ6304011200100, Serial Numbers: 87CZ63040; UDI/DI 01008406821408432187CX6300411180700, Serial Numbers: 87CX63004; UDI/DI 01008406821408432187CX6300911180900, Serial Numbers: 87CX63009; UDI/DI 01008406821408432187CB6307211220700, Serial Numbers: 87CB63072; UDI/DI 01008406821408432187CA6306111211100, Serial Numbers: 87CA63061; UDI/DI 01008406821408432187CY6303211191000, Serial Numbers: 87CY63032; UDI/DI To be provided, Serial Numbers: 87CB63075, 87CA63058, 87CB63070, 87CB63069, 87CB63071, 87CB63077, 87CA63063, 87CB63064, 87CB63078, 87CA63062, 87CB63067, 87CA63057, 87CA63060, 87CB63065, 87CB63068, 87CB63074; UDI/DI Not Applicable, Serial Numbers: 87CY63019, 87CA63054, 87CZ63043, 87CA63055, 87CY63028, 87CY63037, 87CZ63044, 87CZ63045, 87CZ63048, 87CZ63041, 87CY63024, 87CY63017, 87CX63007, 87CX63008, 87CX63006, 87CX63014, 87CY63022, 87CX63015, 87CY63025, 87CX63010, 87CZ63052, 87CY63027, 87CY63026, 87CY63030, 87CZ63046, 87CX63013, 87CY63036, 87CZ63047, 87CY63033, 87CY63016, 87CX63005, 87CZ63039, 87CX63002, 87CX63012, 87CX63001, 87CY63023, 87CY63018; b) D670 CZT Gantry 7.25mm: Catalog number H3906DD, UDI/DI Not Applicable, Serial Numbers: CZGA55003, CZGA55004, CZGY55001; , UDI/DI To be provided, Serial Numbers: CZGB55006, CZGA55005, CZGB55007; c) DISCOV NM/CT 870 CZT: Catalog number H3906CW, UDI/DI 01008406821408432187CY6303811191200, Serial Numbers: 87CY63038; d) Discovery NMCT 670 CZT O540+: Catalog number H3906DD , UDI/DI Not Applicable, Serial Numbers: CZGZ55002; e) NM/CT 870 CZT CYBER DEFENCE: Catalog number H3906FK, UDI/DI To be provided, Serial Numbers: 87DB82001; f) NM/CT 870 CZT O540: Catalog number H3906CW , UDI/DI Not Applicable, Serial Numbers: 87CY63021, 87CZ63050, 87CZ63049, 87CZ63051, 87CY63034; g) NM/CT 870 CZT WSO: Catalog number 5376204-70-20, UDI/DI 01008406821408432187CA6305911210800, Serial Numbers: 87CA63059; UDI/DI 01008406821408432187CB6307611221000, Serial Numbers: 87CB63076; UDI/DI 01008406821408432187CB6307311220800, Serial Numbers: 87CB63073; : Catalog number H3906CW, UDI/DI To be provided, Serial Numbers: 87CB63066; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 87CA63056; h) NM/CT 870 CZT: Catalog number H3906CW, UDI/DI Not Applicable, Serial Numbers: 87CY63031; i) NM/CT 870 CZT O540+ 7.25MM: Catalog number H3906CV, UDI/DI 01008406821408432187CX6300311180700, Serial Numbers: 87CX63003; UDI/DI 01008406821408432187CY6302911190800, Serial Numbers: 87CY63029

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

device · product 6 of 6

GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

Z-1058-2023
Recall number
Z-1058-2023
Initiated
December 19, 2022
Classification
Class I
Status
Ongoing
Quantity
380 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

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

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Code information

a) 850: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2200006BH; b) 850 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2100003BH; c) 850 3/8 inch NM Gantry: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EY67037, 850Z61033, 85EY67039, 85EY67048, 850Y61018, 850Y61009, 85EY67035, 85EX67001, 85EX67020, 85EY67045, 85EX67023, 85EY67032, 85EY67046, 850A61063, 850Z61047, 85EY67047, 850Z61053, 850Y61006, 850Y61010, 850X61005, 850Y61021, 85EZ67062, 85EX67019, 85EX67021, 85EA67063, 850A61069, 85EX67008, 85EY67040, 850Z61051, 850Z61038, 850A61075, 850Y61025, 850Z61030, 85EY67015, 85EX67017, 85EY67043, 850Z61042, 850Z61061, 85EY67026, 850A61065, 85EX67012, 850Y61023, 85EY67041, 850A61062, 850A61076, 850Y61012, 850A61064, 85EZ67058, 85EX67006, 850Z61043, 850Z61055, 85EY67042, 85EZ67055, 85EY67036, 85EX67024, 85EY67038, 85EX67022, 85EY67025, 85EZ67060, 850Z61058, 850Z61044, 850Z61045, 850Y61020, 850Z61032, 85EZ67056, 85EA67065, 85EY67028, 850Z61041, 85EX67002, 85EX67009, 850A61072, 850Z61036, 850A61068, 850A61071, 850Z61060, 850Z61034, 850Z61039, 850Z61035, 850Z61040, 85EY67031, 850Z61056, 850Z61057, 850Y61016, 85EX67016, 85EA67066, 85EX67004, 850Z61029, 850Z61031, 85EX67011, 85EX67010, 850Y61013, 850Y61015, 850Y61017, 850A61070, 85EX67005, 850A61073, 85EX67018, 85EY67033, 850Z61027, 85EX67013, 850Z61054, 850X61001, 85EZ67053, 85EZ67054, 85EZ67057, 850X61004, 850Z61059, 850Z61052, 850Y61014, 850Z61048, 850Y61026, 850Y61019, 85EY67044, 850Z61037, 850X61002, 85EX67003, 85EX67014, 850Y61007, 85EY67049, 85EZ67052, 850A61067, 850A61074, 85EY67050, 85EZ67051, 85EY67027; UDI/DI (01)00840682140775(21)850B61120(11)220700, Serial Numbers: 850B61120; UDI/DI 010084068214077521850Y6101111190300, Serial Numbers: 850Y61011; UDI/DI To be provided, Serial Numbers: 850A61083, 85EA67080, 850B61127, 850B61128, 850B61129, 850B61130, 85EB67087, 850B61133, 850B61134, 850B61135, 850B61101, 85EA67070, 850B61119, 850B61102, 850B61115, 85EA67076, CHBB65669, 850B61122, 850B61132, 850B61131, 85EA67075, 85EA67077, 85EB67088, 850A61093, 85EB67086, 850B61126, 850A61089, 85EA67078, 850B61112, 850B61111, 850B61110, 850B61107, 850B61109; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 60B62111; d) 860 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2100006BH; e) 860 3/8 inch NM Gantry: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Y62009, 860Y62010, 860Z62027, 860Y62005, 860A62049, 860Y62019, 860Y62014, 860Y62025, 860Z62028, 860Y62024, 860Z62038, 860A62063, 860Z62042, 860Y62017, 860A62065, 860A62058, 860Z62046, 860A62057, 860Z62041, 86EA76004, 860B62118, 860Z62043, 860A62060, 860Z62026, 860Y62006, 860Y62015, 860Y62004, 860Z62047, 860Y62020, 860A62050, 860Z62030, 860Y62007, 860X62002, 860Z62032, 860Y62021, 86EA76003, 860Z62040, 860Z62037, 860Z62031, 860A62062; , UDI/DI 010084068214075121860A6207711211000, Serial Numbers: 860A62077; UDI/DI (01)00840682140751(21)860B62097(11)220300, Serial Numbers: 860B62097; UDI/DI 010084068214075121860B6209611220300, Serial Numbers: 860B62096; UDI/DI 010084068214075121860A6205911210400, Serial Numbers: 860A62059; UDI/DI 010084068214075121860A6206811210600, Serial Numbers: 860A62068; UDI/DI 010084068214075121860Y6202311191100, Serial Numbers: 860Y62023; UDI/DI 010084068214075121860Y6201311190600, Serial Numbers: 860Y62013; UDI/DI To be provided, Serial Numbers: 860A62067, 860Y62016, 860B62117, 860B62100, 860B62105, 860B62090, 860A62072, 860B62108, 860B62110, 860A62078, 860A62083, 860B62094, 860A62066, 860A62084, 860A62071, 860A62070, 860A62073, 860A62069, 860B62095, 860A62086, 860A62081, 860A62085, 860B62099, 860B62115, 860A62082, 860B62114, 860A62074, 860Z62034, 86EB76006, 860B62122, 860B62119, 860B62121, 860B62089, 86EB76007, 860A62076, 860A62079, 860B62116, 86EB76009, 860B62120, 860B62093, 860A62080, 860B62098, 860B62091, 860B62103; f) 860 5/8 inch NM Gantry: Catalog number H3908AE, UDI/DI To be provided, Serial Numbers: 860X62001; , UDI/DI Not Applicable, Serial Numbers: 860Z62035; g) 860 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG1900007BH, NT3CG1900008BH, NT3CG1900009BH; h) NM 830 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3AG1900007BH, NT3AG2100001BH, NT3AG2100006BH; i) NM/CT 850 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2000003BH, NT3BG2100001BH, NT3BG2200001BH, NT3BG1900001BH, NT3BG2200002BH, NT3BG2000004BH, NT3BG2100004BH, NT3BG2200005BH; : Catalog number H2407AA, UDI/DI Not Applicable, Serial Numbers: NT3BG2000001BH; , UDI/DI To be provided, Serial Numbers: NT3BG2100002BH; : Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2000002BH; j) NM/CT 850 3/8 inch ROW: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2100005BH, NT3BG1900002BH; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Y61022, 850Z61046, 850Y61008; UDI/DI To be provided, Serial Numbers: 850B61100; k) NM/CT 850 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860Y62008; l) NM/CT 850 CT 850 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850A61092, 850B61108, 850B61096, 850A61080, 850Z61050, 850B61106, 850B61097, 850A61077, 850B61118, 860B62112; Catalog number 5376204-50, UDI/DI 010084068214077521850A6109511211200, Serial Numbers: 850A61095; UDI/DI 010084068214077521850A6108811210900, Serial Numbers: 850A61088; UDI/DI 010084068214077521850B6112111220700, Serial Numbers: 850B61121; UDI/DI 010084068214077521850B6110411220400, Serial Numbers: 850B61104; UDI/DI 010084068214077521850A6108711210900, Serial Numbers: 850A61087; UDI/DI 010084068214077521850A6108211210800, Serial Numbers: 850A61082; UDI/DI 010084068214077521850B6110511220400, Serial Numbers: 850B61105; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 850A61081; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Z61049, 850A61066; UDI/DI To be provided, Serial Numbers: 850B61098, 850B61099, 850A61084, 850B61123, 850B61113, 850B61117, 850B61116, 850A61090, 850A61079, 850A61091, 850B61114, 850A61078, 850A61086; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 850B61125, 850B61103; m) NM/CT 850 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 85EA67068; Catalog number 5376204-50, UDI/DI 01008406821407752185EA6707411210800, Serial Numbers: 85EA67074, 85EA67067, 85EA67073; Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3BG1900003BH; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 85EA67071; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EX67007; UDI/DI To be provided, Serial Numbers: 85EA67069, 85EA67072, 85EA67079, 85EB67084; n) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EZ67059, 85EA67064, 85EY67034; o) NM/CT 860 3/8 inch: Catalog number H3908AD, UDI/DI To be provided, Serial Numbers: 00000860Z62033; p) NM/CT 860 3/8 inch BJ: Catalog number H2408AA, UDI/DI To be provided, Serial Numbers: NT3CG2000001BH; Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2100001BH, NT3CG1900010BH, NT3CG2100003BH, NT3CG1900005BH, NT3CG1900003BH, NT3CG2100004BH, NT3CG1900006BH, NT3CG2100005BH, NT3CG2000004BH, NT3CG1900002BH, NT3CG2100002BH; q) NM/CT 860 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 00000860Y62018; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860A62056, 860Y62011, 860A62048, 860Z62039, 860Z62044, 860A62052, 860A62055, 860Y62012, 860Y62022, 860A62054; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2000003BH; UDI/DI To be provided, Serial Numbers: 860B62102; r) NM/CT 860 ADVANCE: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62045, 860A62064, 860A62061; UDI/DI To be provided, Serial Numbers: 860A62075; Catalog number H3908BB , UDI/DI Not Applicable, Serial Numbers: 8BBB30002, 8BBB30001; s) NM/CT 860 advance 3/8 inch NM Gantry: Catalog number H3908BB, UDI/DI To be provided, Serial Numbers: 8BBB30003, 8BBB30004; t) NM/CT 860 BEYOND: Catalog number H3908BC, UDI/DI Not Applicable, Serial Numbers: 8BCB40001; u) NM/CT 860 beyond 3/8 inch NM Gantry: Catalog number H3908BC, UDI/DI To be provided, Serial Numbers: 8BCB40002; v) NM/CT 860 China for China: Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2200004BH, NT3CG2200003BH, NT3CG2200002BH; , UDI/DI To be provided, Serial Numbers: NT3CG2200001BH; w) NM/CT 860 CT 860 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860B62109, 860Z62029, 860B62101, 860B62113; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62036, 86EZ76001, 860A62053; UDI/DI To be provided, Serial Numbers: 860B62092, 860A62088; x) NM/CT 860 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 86EB76005; y) NM/CT 860 ES 3/8 inch ROW: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 86EA76002; z) NM/CT 850 3/8 inch: Catalog number H3907AA, UDI/DI Not Applicable, Serial Numbers: 850Y61024; aa) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AH, UDI/DI Not Applicable, Serial Numbers: 85EY67030; bb) NM/CT 860 3/8 inch CH: Catalog number H2408AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1900007BH; cc) XELERIS 4 DR WORKSTATION: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850B61124, 850A61094

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.