Reported Jan 22, 2025 · Ongoing
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
Ge Medical Systems Israel, Functional Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Healthcare Optima NM/CT 640
- Model/Catalog Numbers1) H3100JZ; System, Tomography, Computed, Emission
- Lot codes and dates
430 of 430 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID UAB640, Serial Number 26139/25146 2 UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152 3 UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195 4 UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189 5 UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328 6 UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433 7 UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111 8 UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222 9 UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296 10 UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432 11 UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203 12 UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513 13 UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422 14 UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276 15 UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475 16 UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115 17 UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556 18 UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522 19 UDI/DI N/A, System ID 650742OPTIMA, Serial Number ONMX26518/640X25509 20 UDI/DI N/A, System ID 209476OPT1, Serial Number 26338/640V25337 - Amount recalled
- 430 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Why it was recalled
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
This product could cause temporary or reversible health problems — stop using it.
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