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
23 of 23 products
| Model / number | Product as published |
|---|---|
830 | 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) |
870 | NM Gantry 5/8 inch, o) |
B615 | DR NM GANTRY FINAL - NEW ROTOR, p) |
D630 | 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) |
- Lot codes and dates
136 of 136 products
Products covered by this recall Model / number Barcodes Product as published — Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200003, NT3AG2000015BH, NT3AG2100015BH, NT3AG2200006BH — 830 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial numbers: NT3AG2100016BH — 830 /: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100009BH — 830 / 5842894-20: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200013 — 830 / Dismount / 50HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2000017BH — 830 / Dismount / 60HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100001 H3910AC830 3/8 inch Detector: , UDI/DI Not Applicable, Serial Numbers: 830Y60105 — 830 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900009BH 5376204-32-1UDI/DI Not Applicable, Serial Numbers: NT3AG1900015BH — 830 BJ / 5144407: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900008BH 5376204-32-1830 BJ / Dismount: , UDI/DI To be provided, Serial Numbers: NT3AG1900016BH H3910AC830 ES DEM: , UDI/DI Not Applicable, Serial Numbers: 83EZ88002, 830Z60256 H3910AG830 NM Cyber Defense Configuration Gantry 3/8 inch: , UDI/DI Not Applicable, Serial Numbers: 830Z60185, 830Z60224, 830Z60225 H3910AC830 NM Gantry 3/8 inch: , 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 - Amount recalled
- 748 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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