FDA Device recall Z-0890-2025
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY
- 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 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY 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-0890-2025 |
| 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 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; 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) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Ser…1) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1; UDI/DI N/A, System ID NT3111, Serial Number 147243HL0; UDI/DI N/A, System ID NT3072, Serial Number 151822HL4; UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5; UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8; UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1; UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6; UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7; UDI/DI N/A, System ID NT3076, Serial Number 153537HL6; UDI/DI N/A, System ID NT3048, Serial Number 141262HL6; UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6; UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7; UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1; UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3; UDI/DI N/A, Syst |
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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-0890-2025%22
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