FDA Device recall Z-0892-2025
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2 by Ge Medical Systems Israel Functional Imaging, citing 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 Affecte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0892-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems Israel Functional Imaging |
| Distribution | n/a |
Product
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; 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.
Identifiers
| code_info | 1) 5376204-70-56-2: UDI/DI N/A, System IDNT7007, Serial Number NT2JG1800001; UDI/DI N/A, System IDNT4014, Serial Numbe…1) 5376204-70-56-2: UDI/DI N/A, System IDNT7007, Serial Number NT2JG1800001; UDI/DI N/A, System IDNT4014, Serial Number T2HG1700003/ 158624HL7; UDI/DI N/A, System IDNT4017, Serial Number 157120HL7; UDI/DI N/A, System IDNT7001, Serial Number 156620HL7; UDI/DI N/A, System IDNT7005, Serial Number 159731HL9. 2) H2401AW: UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800004; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800005; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800006; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800007; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800008; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800009; UDI/DI 840682140898, System ID LY1198CT02, Serial Number NT2JG1800010; UDI/DI N/A, System ID N/A, Serial Number T2HG1700001; UDI/DI N/A, System ID N/A, Serial Number T2HG1700002; UDI/DI N/A, System ID N/A, Serial Number T2HG1800004; UDI/DI N/A, System ID N/A, Serial Number T2HG1800001; UDI/DI |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0892-2025%22
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