DR 600 SOLID STATE X-RAY IMAGER

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED TO AGFA THE COLLIMATOR OF THEIR AGFA DR 600 SYSTEM BECAME DETACHED AS THEY WERE TWISTING IT. THE CUSTOMER WAS ADJUSTING THE COLLIMATOR TO COMPLETE AN ANKLE X-RAY. THE COLLIMATOR BECAME DETACHED AS IT WAS TWISTED. THE RADIOGRAPHER WAS HOLDING THE COLLIMATOR AT THE TIME SO THE COLLIMATOR DID NOT BECOME COMPLETELY FREE. DURING THE INVESTIGATION BY AGFA, IT WAS CONFIRMED THE COLLIMATOR WAS REMOVED AND MOUNTED AGAIN SEVERAL TIMES BEFORE THE INCIDENT. THE LOCAL SERVICE ENGINEER DID NOT MOUNT THE FIXATION PIN CORRECTLY. THERE IS NO INDICATION FOR A DESIGN PROBLEM OR A PRODUCTION PROBLEM. THIS WAS AN ISOLATED ERROR CAUSED BY THE LOCAL SERVICE ENGINEER. THERE WERE NO BROKEN PARTS OF THE SYSTEM. THE LOCAL SERVICE ENGINEER AGAIN MOUNTED THE COLLIMATOR WITHOUT PROBLEMS. THERE HAVE BEEN NO FURTHER INCIDENTS REPORTED. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.