MalfunctionIZX

SUMMIT SWIVEL COLLIMATOR

Received Jun 26, 2007 · Event occurred Jun 8, 2007

Report 1450503-2007-00002 · MDR key 871844

Device

Generic name

Beam Limiting Device

Manufacturer

Summit Industries, Inc.

Model number

D800

Lot number

NA851-1193

Product problems

Disassembly

Patient

Bruise/Contusion

Narrative

Description of Event or Problem

END USER CALLED SUMMIT DEALER TO ADDRESS "CUT-OFF" ON IMAGES. DEALER SVC REP WENT TO END USER FACILITY AND FOUND COLLIMATOR HANGING BY 2 SCREWS INSTEAD OF 4, TOLD SITE TO DISCONTINUE USE. SUBJECT COLLIMATOR SWIVEL MOUNTING ASSEMBLY WAS REPLACED AND RETURNED TO MANUFACTURER, SUMMIT INDUSTRIES, INC. FOR EVALUATION. THIS INCIDENT IS RELATED TO MFR REPORT# 1450503-2007-00001.

Additional Manufacturer Narrative

THIS INCIDENT IS RELATED TO MFR REPORT# 1450503-2007-00001.

Remedial action

Repair