Z-1462-2012

Allura X-ray System. The Allura X-ray System is an angiographic X-ray system

Name: Z-1462-2012 Allura X-ray System. The Allura X-ray System is an angiographic X-ray system
Creator: Philips Healthcare Inc.
Published: 2012-04-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-04-02 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Allura X-ray System. The Allura X-ray System is an angiographic X-ray system on 2012-04-02. The reason FDA records is "The monitor Ceiling suspension may fail, which may cause the monitor to drop". 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-1462-2012
Status: Terminated
Initiated: 2012-04-02
Posted: 2012-04-25
Terminated: 2014-05-09
Recalling firm: Philips North America LLC
Product: Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The monitor Ceiling suspension may fail, which may cause the monitor to drop.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips sent an "URGENT-FIELD SAFETY NOTICE" dated March 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides information for continued safe and proper use of the equipment. Contact your local Philips representative at 866-767-2822 for further support regarding this issue. Recall expanded 5-2013 to additional 460 units distributed worldwide.
Quantity in commerce: 145
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Belgium, Brazil, Canada, Czech Rep, Chili, China, Columbia, Denmark, Egypt, France, Germany, India, Indonesia, Italy, Japan, Malaysia, Mexico, Morocco, Netherlands, Oman, Russia, Saudi Arabia, Singapore, South Korea, Spain, Thailand, United Kingdom, and Vietnam.
Product codes and lots: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722001, 722003, 722008

Product code IZI

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)