Recall archive / FDA device enforcement
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System — FDA record Z-2098-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Quantity
- 21
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2098-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 16, 2025
- Recall initiation date
- Jun 20, 2025
- Center classification date
- Jul 8, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.