PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
FDA device recall Z-1218-2007 · posted 2007-08-29 · Terminated
Recall details
- Recalling firm
- Summit Industries Inc.
- Reason for recall
- The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZX
- Quantity affected
- 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.
- Date initiated
- 2007-08-10
- Date posted
- 2007-08-29
- Date terminated
- 2010-03-18
- Location
- Chicago, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLI-MATETM MODEL NO. B800 (K874687) | Summit Industries, Inc. | 1987-12-30 |