Z-2098-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2025
- Initiation Date
- June 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
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