Z-0547-2011

ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are...

Name: Z-0547-2011 ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2009-05-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-05-26 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems North America Co. Phillips began a recall of ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray... on 2009-05-26. The reason FDA records is "The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0547-2011
Status: Terminated
Initiated: 2009-05-26
Posted: 2010-12-07
Terminated: 2010-12-09
Recalling firm: Philips North America LLC
Product: ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Philips began mailing out an URGENT-Device Correction letter on May 26, 2009. Philips sent out a second URGENT-Device Correction letter dated June 4, 2009, to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to contact their local Philips representative immediately if their system completely shut down and would not restart. A mandatory Field Change Order 72200144 was issued for replacement of the Printed Circuit Board (PCB) in the Allura XPER FD system. A mandatory Field Change Order FCO 70800091 was issued for replacement of the Printed Circuit Board (PCB) in the MultiDiagnost Eleva with FD system. The consignees were to be contacted by their Philips Representative for implementation of the corrective action. The firm's Field Engineer would replace the power tray of the systems. If the consignees needed any further information or support concerning this issue, they were to contact the call Center at 800-722-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.
Quantity in commerce: 6 units
Distribution: Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.
Product codes and lots: Site numbers: 41660520, 43043666, 43164789, 43848923, 44028554, and 105082.

Product code IZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)