Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1217-2007

LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago...

Summit Industries, LLC / initiated 2007-08-10 / Terminated

Summit Industries Inc. began a recall of LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois on . The reason FDA records is "The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1217-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Summit Industries, LLC
Product
LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
Product code
IZX Collimator, Manual, Radiographic
Reason for recall
The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
FDA root cause
Other
Action
The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.
Quantity in commerce
3034 for all units
Distribution
Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.
Product codes and lots
Model E600, serial numbers VA163-1192 to VB985-0798, all swivel units manufactured between 11/14/1992 and 07/31/1998