PROTEUS

Additional Manufacturer Narrative

THE GE HEALTHCARE INVESTIGATION HAS CONCLUDED THAT THE COLLIMATOR DETACHMENT WAS CAUSED BY A HARDWARE FAILURE. A GE HEALTHCARE FIELD ENGINEER (GEHC FE) INSPECTED THE SYSTEM AND FOUND THAT A LOOSENED LOCKING SCREW LED TO THE COLLIMATOR DETACHING AND FALLING. THE DETACHED COLLIMATOR WAS RETURNED TO THE GEHC ENGINEERING TEAM FOR FURTHER ANALYSIS. IT WAS OBSERVED THE SPLIT RING WASHER USED WITH THE MAIN LOCKING SCREW WAS DEFORMED AND HAD BECOME STUCK ON THE SCREW HEAD. IN THIS CONDITION, THE WASHER COULD NOT EFFECTIVELY PREVENT THE SCREW FROM LOOSENING. TO RESOLVE THE ISSUE, THE COLLIMATOR WAS REPLACED. NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

ON (B)(6) 2025, THE CUSTOMER AT (B)(6) HOSPITAL LOCATED IN USA REPORTED THAT DURING A PATIENT EXAM WHILE USING THEIR PROTEUS FIXED RADIOGRAPHIC X-RAY SYSTEM, THE COLLIMATOR DETACHED FROM THE TUBE SUPPORT AND FELL. THE COLLIMATOR DID IMPACT THE PATIENT'S LEG WHEN IT DROPPED RESULTING IN A MINOR SCRAPE WITH NO BROKEN SKIN. NO MEDICAL TREATMENT WAS REQUIRED.

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. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. GE HEALTHCARES INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.