FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Allura Xper FD10/10 x-ray system
- Recall number
- Z-0581-06
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Allura Xper FD10/10 x-ray system
- Status
- Terminated
- Initiated
- 2006-02-06
- Posted
- 2006-02-28
- Terminated
- 2008-05-20
- Reason
- Potential lock-up of system requiring reboot of system.
- Root cause
- Other
- Action
- On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices.
- Quantity
- 55 devices total (Allura Xper FD10/10 & Allura Xper FD10)
- Distribution
- Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.
- Lot, serial or model codes
- Site numbers 533762, 534634, 535667, 534678, 532799, 532800, 539107, 537630, 534638, 533278, 533282, 533283, 538514, 540016, 538744, 538485, 538486, 535415, 538028, 532614, 533476, 538409, 536789, 538516, 532611, 538157, 538368, 536715, 534731, 540841, 537804, 522138, 538903, 538476, 536899, 536028, 540237, 530666, 530667, 533619, 537698, 539628, 541276, 537745, 531942, 542113, 542117, 536138, 533289, 536031, 536034, 536035, 536037, 536042, 540234
- 510(k) numbers
- ["K031333"]
- 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