Recalling Firm / Manufacturer

Summit Industries Inc.

Product

PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois

Code Information

Model F100, serial numbers WA153-1092 to WA153-0697, all swivel units manufactured between 10/01/1992 and 06/30/1997

Reason of Recall

The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

Date Recall Initiated

August 10, 2007

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. Firm Initiated recall is ongoing.

Contact

N/A

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.