Z-0161-2007

Allura Xper FD 10/10 x-ray, angiographic system

Name: Z-0161-2007 Allura Xper FD 10/10 x-ray, angiographic system
Creator: Philips Medical Systems North America Co. Phillips
Published: 2006-08-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-08-24 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Allura Xper FD 10/10 x-ray, angiographic system on 2006-08-24. The reason FDA records is "Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0161-2007
Status: Terminated
Initiated: 2006-08-24
Posted: 2006-11-08
Terminated: 2008-05-29
Recalling firm: Philips North America LLC
Product: Allura Xper FD 10/10 x-ray, angiographic system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.
FDA 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 in commerce: 90 total devices - FD 10/10 & FD 10
Distribution: Nationwide.
Product codes and lots: 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

Product code IZI

K041949Class IIAllura Xper Fd10Philips Medical Systems North America Co. / cleared 2004-07-30

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)