Z-0125-2011

Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging...

Name: Z-0125-2011 Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-08-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-08-21 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional... on 2008-08-21. The reason FDA records is "Potential for table and stand not to move due to a software error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0125-2011
Status: Terminated
Initiated: 2008-08-21
Posted: 2010-10-22
Terminated: 2010-11-19
Recalling firm: Philips North America LLC
Product: Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Potential for table and stand not to move due to a software error.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software. For question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.
Quantity in commerce: 26 units
Distribution: Devices were distributed to hospitals and medical facilities through out the U.S.
Product codes and lots: Devices are identified with Site Numbers: 103281, 103283, 505903, 506119, 530653, 536715, 543411, 545396, 547823, 549368, 552969, 554802, 554970, 555293, 555299, 555834, 41443647, 41443804, 41444650, 41445448, 41445501, 41445538, 41455920, 41780160, 42057324, and 42064724.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)