FDA Medical Device Recalls (openFDA)
Allen Medical Systems, Inc.: Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.
- Recall number
- Z-1478-2008
- Recalling firm
- Allen Medical Systems, Inc.
- Product
- Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.
- Status
- Terminated
- Initiated
- 2007-11-27
- Posted
- 2008-08-20
- Terminated
- 2008-08-26
- Reason
- Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.
- Root cause
- Device Design
- Action
- Allen Medical notified accounts by telephone on 11/08/07 and the Sales Representative. The Hospitals confirmed that the device would be sent back for evaluation and upgraded.
- Quantity
- 2
- Distribution
- MA, MS
- Lot, serial or model codes
- Serial Numbers: A111211, A116292
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCX
- Firm FEI
- 1221538
- Firm city
- Acton
- Firm state
- MA
- 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