Recall archive / FDA device enforcement
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission — FDA record Z-0894-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Quantity
- 17 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0894-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 22, 2025
- Recall initiation date
- Dec 18, 2024
- Center classification date
- Jan 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.