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U.S. Department of Health and Human Services

Class 2 Device Recall Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH

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 Class 2 Device Recall Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VHsee related information
Date Initiated by FirmJune 20, 2025
Date PostedJuly 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2098-2025
Recall Event ID 97193
510(K)NumberK953801 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductVaricam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Code Information 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
Recalling Firm/
Manufacturer		 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
4, Hayozma St
Tirat Carmel Israel
For Additional Information ContactGE HealthCare Service
800-4371171
Manufacturer 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 2		Software design
ActionFirm 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 in Commerce21
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPS
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