OPTIMA
Received Jan 28, 2026 · Event occurred Dec 15, 2025
Report 9613445-2026-00002 · MDR key 24197429
Device
Generic name
Interventional Fluoroscopic X-ray
Manufacturer
Ge Hangwei Medical Systems Co., Ltd.Model number
IGS 320 001Product problems
- Radiation Output Failure
Patient
NA · Unknown
- Cardiac Arrest
Narrative
Additional Manufacturer Narrative
LEGAL MANUFACTURER: HCS BEIJING - WEST AREA OF BUILDING NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA CHINA BEIJING, 100176, GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
DURING AN EMERGENCY CARDIAC EXAMINATION ON (B)(6) 2025 THE GE HEALTHCARE SYSTEM WAS UNABLE TO INITIATE X RAY IMAGING DUE TO A SUSPECTED X RAY TUBE FAILURE, DESPITE MULTIPLE RESET ATTEMPTS. THE EXAMINATION COULD NOT BE PERFORMED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY LOCATED ~20 KM AWAY, WHERE A PROCEDURE USING ANOTHER DEVICE WAS INITIATED. GE HEALTHCARE WAS INFORMED THAT THE PATIENT SUBSEQUENTLY DIED AT THE SECOND FACILITY.