PROTEUS

Additional Manufacturer Narrative

LEGAL MANUFACTURER: GE HANGWEI MEDICAL SYSTEMS CO., LTD. WEST AREA OF BUILDING NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA, BEIJING, CHINA 100176. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. GE HEALTHCARE¿S 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 (B)(6) 2026, A USER AT (B)(6) (USA) REPORTED AN INCIDENT THAT OCCURRED ON (B)(6) 2026 INVOLVING THE OVERHEAD TUBE SUSPENSION (OTS) OF THEIR PROTEUS FIXED RADIOGRAPHIC IMAGING SYSTEM. ACCORDING TO THE REPORT, DURING ROUTINE CLEANING OF THE TABLETOP, THE TECHNOLOGIST LIFTED THEIR HEAD AND CONTACTED THE UNDERSIDE OF THE OTS GOOSENECK ASSEMBLY. THE CONTACT REPORTEDLY RESULTED IN A LACERATION TO THE TOP OF THE TECHNOLOGIST¿S HEAD. THE TECHNOLOGIST RECEIVED MEDICAL TREATMENT CONSISTING OF TWO STAPLES AND ONE SUTURE. BASED ON THE INFORMATION PROVIDED, THE DEVICE WAS STATIONARY AND OPERATING AS INTENDED AT THE TIME OF THE EVENT. NO DEVICE MALFUNCTION, UNEXPECTED MOVEMENT, OR MECHANICAL FAILURE OF THE OTS ASSEMBLY WAS REPORTED.