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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 system see related information
Date Initiated by Firm April 02, 2012
Date Posted April 25, 2012
Recall Status1 Terminated 3 on May 09, 2014
Recall Number Z-1462-2012
Recall Event ID 61514
510(K)Number K031333  K033737  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Allura 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 
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Dominic 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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