FDA Medical Device Recalls (openFDA)
Summit Industries Inc.: PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
- Recall number
- Z-1218-2007
- Recalling firm
- Summit Industries Inc.
- Product
- PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
- Status
- Terminated
- Initiated
- 2007-08-10
- Posted
- 2007-08-29
- Terminated
- 2010-03-18
- 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 was instructed to take the unit out of service and call the dealer.
- 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.
- Lot, serial or model codes
- Model F100, serial numbers WA153-1092 to WA153-0697, all swivel units manufactured between 10/01/1992 and 06/30/1997
- 510(k) numbers
- ["K874687"]
- PMA numbers
- not on file
- Product code
- IZX
- Firm FEI
- 1450503
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28