Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Recall
- Recall Number
- Z-2097-2025
- Event Number
- 97193
- Firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel
- FEI Number
- 3004571294
- Product Code
- KPS
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- June 20, 2025
- Posted
- July 8, 2025
Description
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
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.
Worldwide - US Nationwide distribution.
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