Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
FDA Recall Z-1462-2012 · Posted 2012-04-25
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeIZI
Date Initiated2012-04-02
Date Terminated2014-05-09
Product Quantity145
Reason for Recall
The monitor Ceiling suspension may fail, which may cause the monitor to drop.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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