Recall Z-2098-2025
GE Medical Systems Israel, Functional Imaging · initiated June 20, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Codes / lots: 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
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.
FDA-determined cause: Software design
Action taken
Firm notified customers via Urgent Medical Device Correction letter dated June 20, 2025. Customers were instructed to check gantry software version. Instructions to do so are included in the letter. If system has the correct gantry software version, customers may continue to use their system--V.25BK for Infinia Running on Windows2000 (Win2K); C.15BK or C.1523 for Infinia on Windows XP; V.60BK on VG (all operating systems). If the software version is not the correct version, customers should discontinue use of system and contact GE HealthCare Service or local Service Representative. GE HealthCare will correct systems at no cost to the customer. Correction will include a hardware update and, if necessary, a software update. GE HealthCare representatives will contact customers to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-2098-2025
- Initiated
- June 20, 2025
- Posted by FDA
- July 8, 2025
- Product code
- KPS – System, Tomography, Computed, Emission
- Quantity
- 21
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- GE Medical Systems Israel, Functional Imaging, Tirat Carmel
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2097-2025 Class II | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine systemUnintended radial detector motion may occur during patient setup or during patient scan if system does not… | 06/20/2025Open, Classified |