Device product
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Z-2098-2025
Product summary
- Event
- Event 97193
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-2098-2025
Official wording
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.
Code information: 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
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Device software or design
software installed. Unintended detector motion may result in