FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Allura Xper FD 10 x-ray, angiographic system
- Recall number
- Z-0162-2007
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Allura Xper FD 10 x-ray, angiographic system
- Status
- Terminated
- Initiated
- 2006-08-24
- Posted
- 2006-11-08
- Terminated
- 2008-05-29
- Reason
- Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.
- Root cause
- Other
- Action
- A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.
- Quantity
- 90 total devices - FD 10/10 & FD 10
- Distribution
- Nationwide.
- Lot, serial or model codes
- Site codes listed in Z-0161-2007 for FD 10/10.
- 510(k) numbers
- ["K041949"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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