FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Allura Xper FD 10/10 x-ray, angiographic system
- Recall number
- Z-0161-2007
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Allura Xper FD 10/10 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 numbers for both FD 10/10 and FD 10: 532800, 544506, 543702, 543289, 543209, 543200, 543194, 542714, 542557, 542413, 542117, 542113, 541822, 541592, 541577, 541409, 541029, 541026, 540841, 540488, 540386, 540311, 540301, 540269, 540237, 540235, 540234, 540184, 540070, 540016, 539641, 539628, 539595, 539480, 539455, 539326, 539107, 538903, 538744, 538516, 538514, 538486, 538485, 538476, 538409, 538368, 538157, 538084, 538028, 537855, 537804, 537745, 537698, 537631, 537630, 536966, 536721, 536379, 536138, 536042, 536037, 536035, 536034, 536031, 536028, 535769, 535667, 535416, 535415, 534941, 534731, 534678, 534638, 534634, 533762, 533397, 533289, 533283, 533282, 533278, 532799, 532611, 531942, 530667, 530666, 104497, 103283
- 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
- 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