FDA Medical devices recall ·
GE Healthcare Discovery NM/CT 670 ES, Model recall
- Recall number
- Z-0894-2025
- 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
- 17 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; 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) H3100XF: UDI/DI N/A, System ID NT1011, Serial Number T2AG12009/ 88227HL4; UDI/DI N/A, System ID NT2002, Serial Number T2AG12011/ 89154HL9; UDI/DI N/A, System ID NT1009, Serial Number T2AG12013/ 90088HL6; UDI/DI N/A, System ID NT1003, Serial Number T2BG11001/ 79573HL2; UDI/DI N/A, System ID NT1004, Serial Number T2AG12003/ 79574HL0; UDI/DI N/A, System ID NT1005, Serial Number 84775HL6; UDI/DI N/A, System ID NT1020, Serial Number T2AG12012/ 89666HL2; UDI/DI N/A, System ID NT1016, Serial Number T2AG13020/ 96237HL3; UDI/DI N/A, System ID NT0002, Serial Number 106491HL4; UDI/DI N/A, System ID NT2004, Serial Number 105724HL9; UDI/DI N/A, System ID NT1012, Serial Number T2AG13016/ 93885HL2; UDI/DI N/A, System ID NT1012, Serial Number T2AG13017/ 93885HL2; UDI/DI N/A, System ID NT1013, Serial Number 94165HL8; UDI/DI N/A, System ID NT1010, Serial Number T2AG12008/ 87697HL9; UDI/DI N/A, System ID NT3001, Serial Number 85748HL2; UDI/DI N/A, System ID NT1017, Serial Number T2AG13027/ 104213HL4; UDI/DI N/A, System ID NT1015, Serial Number T2AG13018/ 94292HL0.
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-0894-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.