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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical Systems Allura Xper FD20C

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  Class 2 Device Recall Philips Medical Systems Allura Xper FD20C see related information
Date Initiated by Firm July 08, 2014
Date Posted November 07, 2014
Recall Status1 Terminated 3 on January 18, 2017
Recall Number Z-0182-2015
Recall Event ID 68723
510(K)Number K033737  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Philips Medical Systems Allura Xper FD20C with software version R8.2.O
System Code: 722035.

The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Code Information Allura Xper Software version R8.2.0 
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
FDA Determined
Cause 2		 Software design
Action Philips Medical Systems issued certified letters on 7/8/14 and receipt returned for tracking purposes. A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3. If you need any further information or support concerning this issue, contact your local Philips representative: SUPPORT 1-800-722-9377.
Quantity in Commerce 2 units
Distribution Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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