FDA Device recall Z-0893-2025
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2
- 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 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2 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-0893-2025 |
| 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 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; 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) 5376204-70-54-2: UDI/DI N/A, System ID NT4011, Serial Number 131640HL5; UDI/DI N/A, System ID NT1023, Serial Number…1) 5376204-70-54-2: UDI/DI N/A, System ID NT4011, Serial Number 131640HL5; UDI/DI N/A, System ID NT1023, Serial Number 154472HL5; UDI/DI N/A, System ID NT4003, Serial Number 128062HL7; UDI/DI N/A, System ID NT4005, Serial Number 128536HL0; UDI/DI N/A, System ID NT1022, Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A, System ID 83131625480, Serial Number T27G15012/131277HL6; UDI/DI N/A, System ID 83119512125, Serial Number T2AG14038/0; UDI/DI N/A, System ID 83151204341, Serial Number T27G1600025/0; UDI/DI N/A, System ID 83153611901, Serial Number T27G1700030/147506HL0; UDI/DI N/A, System ID 83136989873, Serial Number T27G15006/GLX-TAN-03716; UDI/DI N/A, System ID 83114701360, Serial Number T2AG14036/112879HL2; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700034/150126HL1; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700033/150126HL1; UDI/DI N/A, System ID Not Available, Serial Number T27G15005/126820HL0; UDI/DI N/A, System ID 600002NM01, Serial Number T27G15004/12 |
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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-0893-2025%22
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