Z-0581-06

Allura Xper FD10/10 x-ray system

Name: Z-0581-06 Allura Xper FD10/10 x-ray system
Creator: Philips Medical Systems North America Co. Phillips
Published: 2006-02-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-02-06 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Allura Xper FD10/10 x-ray system on 2006-02-06. The reason FDA records is "Potential lock-up of system requiring reboot of system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0581-06
Status: Terminated
Initiated: 2006-02-06
Posted: 2006-02-28
Terminated: 2008-05-20
Recalling firm: Philips North America LLC
Product: Allura Xper FD10/10 x-ray system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Potential lock-up of system requiring reboot of system.
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code IZI

K031333Class IIPhilips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. / cleared 2003-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)