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
9 of 9 products
| # | Product as published |
|---|---|
| 1 | 870 CZT O540+ Gantry 7.25mm |
| 2 | D670 CZT Gantry 7.25mm |
| 3 | DISCOV NM/CT 870 CZT |
| 4 | Discovery NMCT 670 CZT O540+ |
| 5 | NM/CT 870 CZT CYBER DEFENCE |
| 6 | NM/CT 870 CZT O540 |
| 7 | NM/CT 870 CZT WSO |
| 8 | NM/CT 870 CZT |
| 9 | NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System |
- Lot codes and dates
- a) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW , UDI/DI 01008406821408432187CZ6304211200300
- Serial Numbers
87CZ63042UDI/DI 01008406821408432187CA6305311210100
- Serial Numbers
87CA63053UDI/DI 01008406821408432187CX6301111181000
- Serial Numbers
87CX63011UDI/DI 01008406821408432187CY6302011190300
- Serial Numbers
87CY63020UDI/DI 01008406821408432187CY6303511191100
- Serial Numbers
87CY63035UDI/DI 01008406821408432187CZ6304011200100
- Serial Numbers
87CZ63040UDI/DI 01008406821408432187CX6300411180700
- Serial Numbers
87CX63004UDI/DI 01008406821408432187CX6300911180900
- Serial Numbers
87CX63009UDI/DI 01008406821408432187CB6307211220700
- Serial Numbers
87CB63072UDI/DI 01008406821408432187CA6306111211100
- Serial Numbers
87CA63061UDI/DI 01008406821408432187CY6303211191000
- Serial Numbers87CY63032; UDI/DI To be provided
- Serial Numbers
87CB6307587CA6305887CB6307087CB6306987CB6307187CB6307787CA6306387CB6306487CB6307887CA6306287CB6306787CA6305787CA6306087CB6306587CB6306887CB63074UDI/DI Not Applicable
- Serial Numbers87CY63019, 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
CZGA55003CZGA55004CZGY55001UDI/DI To be provided
- Serial Numbers
CZGB55006CZGA55005CZGB55007
- c) DISCOV NM/CT 870 CZT
Catalog number H3906CWUDI/DI 01008406821408432187CY6303811191200
- Serial Numbers87CY63038; d) Discovery NMCT 670 CZT O540+: Catalog number H3906DD , UDI/DI Not Applicable
- Serial NumbersCZGZ55002
- e) NM/CT 870 CZT CYBER DEFENCECatalog number H3906FK, UDI/DI To be provided
- Serial Numbers87DB82001
- f) NM/CT 870 CZT O540Catalog number H3906CW , UDI/DI Not Applicable
- Serial Numbers
87CY6302187CZ6305087CZ6304987CZ6305187CY63034
- g) NM/CT 870 CZT WSO
Catalog number 5376204-70-20UDI/DI 01008406821408432187CA6305911210800
- Serial Numbers
87CA63059UDI/DI 01008406821408432187CB6307611221000
- Serial Numbers
87CB63076UDI/DI 01008406821408432187CB6307311220800
- Serial Numbers
87CB63073: Catalog number H3906CWUDI/DI To be provided
- Serial Numbers87CB63066; : Catalog number To be provided, UDI/DI To be provided
- Serial Numbers87CA63056
- h) NM/CT 870 CZTCatalog number H3906CW, UDI/DI Not Applicable
- Serial Numbers87CY63031; i) NM/CT 870 CZT O540+ 7.25MM: Catalog number H3906CV, UDI/DI 01008406821408432187CX6300311180700
- Serial Numbers
87CX63003UDI/DI 01008406821408432187CY6302911190800
- Serial Numbers87CY63029
- Amount recalled
- 86 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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