GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Varicam

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2098-2025
• FDA 510(k) clearance · K953801The device's official FDA premarket clearance record
• FDA device classification · KPSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.