FDA Medical devices recall ·
Varicam, Millennium VG, Millennium VG Hawkeye… recall
- Recall number
- Z-2098-2025
- Date
- (initiated June 20, 2025)
- Company / brand
- Ge Medical Systems Israel, Functional Imaging
4, Hayozma St, Tirat Carmel, N/A, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21
- Hazard tags
- Software Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 ***Updated 9/9/26*** Additional Serial Nos. ELSCINT VARICAM V-1530 V-1696 Not Available/V2309 8125-17-16 343 2488 1958 Not Available/E5516APEX 8125-16-25 1617 1008 VG GANTRY ASSY 1144
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2098-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.