FDA Medical devices recall ·
GE Healthcare Optima NM/CT 640, Model recall
- Recall number
- Z-0896-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Ge Medical Systems Israel, Functional Imaging
4, Hayozma St, Tirat Carmel, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 430 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189; UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328; UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433; UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111; UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222; UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296; UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432; UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203; UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513; UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422; UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276; UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475; UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115; UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556; UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522; UDI/DI N/A, System ID 650742OPTIMA, Serial Number ONMX26518/640X25509; UDI/DI N/A, System ID 209476OPT1, Serial Number 26338/640V25337; UDI/DI N/A, System ID 310222NM640, Serial Number ONMW26418/640W25413; UDI/DI N/A, System ID 707554OPT1, Serial Number 26140/25145; UDI/DI N/A, System ID 303695NM1, Serial Number ONMW26436/64
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0896-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.