GE Nuclear Medicine 600/800 series systems recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

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 /…

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Quantity

557 units

Distribution

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.

Recall date

February 15, 2023

Classification

Class I

Status

Ongoing

Agency

FDA (device)