Reported Feb 15, 2023 · Ongoing
GE Nuclear Medicine 600/800 series systems, specifically
Ge Medical Systems Israel, Functional Imaging
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 4, Hayozma St · Tirat Carmel · N/A
Is this the product you have?
GE Nuclear Medicine 600/800 series systems, specifically
30 of 30 products
| Model / number | Product as published |
|---|---|
870 | 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 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) |
D670 | 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) |
- Lot codes and dates
93 of 93 products
Products covered by this recall Model / number Product as published — Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2200004, NT3DG2200009, NT3DG2200018, NT3DG2200002 5376204-70-60-1870 DR 3/8" NM GANTRY WITH NEW ROTOR - MEA: , UDI/DI Not Applicable, Serial Numbers: NT3DG2100018BH — 870 DR / Dismount: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100006 — 870 DR / Dismount / 60HZ: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2000016BH H3906EM870 DR 3/8" WSO: , UDI/DI Not Applicable, Serial Numbers: 870B64224, 870Z64148 H3100AS870 DR 3/8" NM Gantry: , 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 H3100AP870 DR 3/8": , UDI/DI Not Applicable, Serial Numbers: 870Y64034 — UDI/DI 010084068214083621870X6401511180900, Serial Numbers: 870X64015 H2402AG870 DR 3/8" CH: , UDI/DI To be provided, Serial Numbers: NT3DG1900005BH — UDI/DI Not Applicable, Serial Numbers: NT3DG1800002BH H3100Q870 DR 5/8" NM GANTRY: , UDI/DI 010084068214083621870X6401811181000, Serial Numbers: 870X64017 — UDI/DI 010084068214083621870Y6406611190700, Serial Numbers: 870Y64066 — UDI/DI Not Applicable, Serial Numbers: 870Y64045, 870A64201, 00000870X64014, 870Y64041 — 870 DR BJ / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG1900013BH H3906FF870 DR CyberDefense 3/8" NM Gantry: , UDI/DI Not Applicable, Serial Numbers: 87CA83004, 87CA83001 — UDI/DI To be provided, Serial Numbers: 87CA83002, 87ZA83005 H3100AS870 DR NM GANTRY FINAL - NEW ROTOR: , UDI/DI To be provided, Serial Numbers: 870B64288, 00000870Z64139 — 870 DR China: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100016BH 5791566D670 NM GANTRY WITH NEW ROTOR: , UDI/DI To be provided, Serial Numbers: 870A64203, 87EA77013, 870B64255 5791566D670 DR 3/8" 16 SL: , UDI/DI To be provided, Serial Numbers: DRGY56031, DRGY56025 - Amount recalled
- 557 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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