FDA Device recall Z-2098-2025
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- FDA Device
- Class II
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class II recall of Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System by Ge Medical Systems Israel Functional Imaging, citing unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2098-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems Israel Functional Imaging |
| Distribution | US |
Product
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Reason
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Identifiers
| code_info | Serial Numbers: Millennium VG 1074; "Varicam Millennium VG Discovery VH" 1003 1092 10147 10242 10374 10378 10539 1054…Serial Numbers: Millennium VG 1074; "Varicam Millennium VG Discovery VH" 1003 1092 10147 10242 10374 10378 10539 10543 10550 10553 10561 10569 10570 10571 10579 10582 10587 10599 10604 3101-1502 |
|---|
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-2098-2025%22
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