FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II).
- Recall number
- Z-0368-2007
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II).
- Status
- Terminated
- Initiated
- 2006-12-14
- Posted
- 2007-01-25
- Terminated
- 2011-10-14
- Reason
- Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Root cause
- Other
- Action
- On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.
- Quantity
- 140 devices total
- Distribution
- Units were distributed to hospitals and medical centers nationwide.
- Lot, serial or model codes
- site numbers provided in the product listing for Z-0366-2007
- 510(k) numbers
- ["K022899"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- 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