SUMMIT SWIVEL COLLIMATOR
Received Jul 17, 2014 · Event occurred Jun 5, 2014
Report 1450503-2014-00001 · MDR key 3972768
Device
Product problems
- Component Falling
Patient
40 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A SUMMIT SWIVEL COLLIMATOR, MODEL # D800, FELL FROM TUBE STAND AND CONTACTED THE LEG OF A PT. PT WAS EXAMINED BY A HEALTHCARE PROFESSIONAL AND RELEASED. NO ADDITIONAL TREATMENT NECESSARY.
Additional Manufacturer Narrative
THE COLLIMATOR IDENTIFIED IN THIS REPORT WAS THE SUBJECT OF A RECALL (NUMBERS Z-1216/1218-2007) INITIATED ON MAY 22, 2007 FOR THIS SAME PROBLEM. THIS COLLIMATOR WAS SOLD TO A DISTRIBUTOR WHO WENT OUT OF BUSINESS PRIOR TO THE RECALL. THERE WERE OVER 3000 COLLIMATORS INVOLVED IN THE RECALL AND TODAY ALL THAT MAY BE REMAINING IN USE ARE BETWEEN 13 AND 21 YEARS OLD. BETWEEN JULY 2007 AND JANUARY 2010 SUMMIT INDUSTRIES MADE A BEST FAITH EFFORT TO LOCATE AND REPAIR AS MANY OF THESE COLLIMATORS AS POSSIBLE. DUE TO THE AGE OF THE COLLIMATOR WE WERE NOT ABLE TO LOCATE ALL. SUMMIT'S FINAL REPORT WAS SUBMITTED TO THE FDA ON JANUARY 18, 2010 AND THE RECALL WAS REPORTED "TERMINATED" IN A LETTER (RECEIVED BY SUMMIT INDUSTRIES) FROM THE FDA IN MARCH OF 2010.
Remedial action
- Repair