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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xray system

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 Class 2 Device Recall Allura Xray systemsee related information
Date Initiated by FirmApril 02, 2012
Date PostedApril 25, 2012
Recall Status1 Terminated 3 on May 09, 2014
Recall NumberZ-1462-2012
Recall Event ID 61514
510(K)NumberK031333 K033737 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductAllura X-ray System. The Allura X-ray System is an angiographic X-ray system.
Code Information 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722001, 722003, 722008 
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information ContactDominic Siewko
978-687-1501
Manufacturer Reason
for Recall		The monitor Ceiling suspension may fail, which may cause the monitor to drop.
FDA Determined
Cause 2		Process control
ActionPhilips 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 Commerce145
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZI
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