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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
