PROTEUS

Additional Manufacturer Narrative

GE HEALTHCARE INVESTIGATION DETERMINED THAT THE COLLIMATOR DETACHMENT WAS CAUSED BY A SERVICE ERROR. THE GE HEALTHCARE FIELD ENGINEER (FE) DID NOT USE A TORQUE WRENCH TO TIGHTEN THE COLLIMATOR CLAMPING SCREW TO THE SPECIFIED 5.6 NM, AS OUTLINED IN THE SYSTEM SERVICE MANUAL. ALTHOUGH THE TORQUE WRENCH WAS AVAILABLE, THE FE INADVERTENTLY LEFT IT IN HIS WORK VAN. THE ISSUE WAS CORRECTED ON-SITE BY REINSTALLING THE COLLIMATOR PER THE SERVICE MANUAL. THE FE WAS ALSO REMINDED THE IMPORTANCE OF USING THE TORQUE WRENCH FOR THIS PROCEDURE MOVING FORWARD. NO FURTHER ACTIONS ARE 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 HEALTHCARE INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

ON 22-JUN-2025, CLINICAL PERSONNEL AT (B)(6) REPORTED A MECHANICAL FAILURE INVOLVING A PROTEUS FIXED RADIOGRAPHIC X-RAY SYSTEM. DURING PATIENT EXAM PREPARATION, THE COLLIMATOR ASSEMBLY BECAME DETACHED FROM THE OVERHEAD TUBE SUSPENSION (OTS). THE DETACHMENT OCCURRED WITHOUT CONTACT WITH STAFF OR PATIENTS, AND NO INJURIES WERE REPORTED.