Z-0165-2007

Allura X-per FD 10/10 x-ray, and fluoroscopy

Name: Z-0165-2007 Allura X-per FD 10/10 x-ray, and fluoroscopy
Creator: Philips Medical Systems North America Co. Phillips
Published: 2006-10-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-10-12 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Allura X-per FD 10/10 x-ray, and fluoroscopy on 2006-10-12. The reason FDA records is "Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0165-2007
Status: Terminated
Initiated: 2006-10-12
Posted: 2006-11-14
Terminated: 2010-09-24
Recalling firm: Philips North America LLC
Product: Allura X-per FD 10/10 x-ray, and fluoroscopy
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
FDA root cause: Other
Action: On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers.
Quantity in commerce: 47 devices
Distribution: Nationwide.
Product codes and lots: 127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95, 27, 6, 47, 98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89, 23, 33, 31, 30, 29, 28, 32, 100, 63, 61 Additional units are identified with site numbers: 533397, 531926, 104950, 104953, 103283, 103281, 530653, 104497

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)