FDA Enforcement
Class II
Ongoing
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Recall: Z-2098-2025
·
Reported July 16, 2025
Enforcement
- Recall Number
- Z-2098-2025
- Event ID
- 97193
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 16, 2025
- Initiation Date
- June 20, 2025
- Classification Date
- July 8, 2025
- Address
- 4, Hayozma St, N/A, Tirat Carmel, N/A, N/A, Israel
Description
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.
Code Info
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
Worldwide - US Nationwide distribution.
Quantity
21