FDA Medical Device Recalls (openFDA)
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- Recall number
- Z-2098-2025
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product
- Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- Status
- Open, Classified
- Initiated
- 2025-06-20
- Posted
- 2025-07-08
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 21
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K953801"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 3004571294
- Firm city
- Tirat Carmel
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28