Recall Z-1218-2007 ยท IZX Collimator, Manual, Radiographic
Summit Industries Inc.
PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
| Date | Aug 29, 2007 (initiated Aug 10, 2007) |
| Status | Terminated |
| Reason | The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. |
| 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 w |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874687 | COLLI-MATETM MODEL NO. B800 Summit Industries, Inc., Dec 30, 1987 |