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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm November 03, 2015
Date Posted February 05, 2016
Recall Status1 Terminated 3 on August 19, 2016
Recall Number Z-0764-2016
Recall Event ID 72571
510(K)Number K033737  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Code Information Ceiling version only.
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).
FDA Determined
Cause 2		 Device Design
Action The letters for the customers in the United States were sent on 11/3/2015, via certified return receipt and were addressed to the Risk Manager. Philips will perform a test on the 15 affected Allura Xper R8.2 FD 20C systems to see if the motion controller amplifier of the brake motor works correctly. If the test will not pass, the motor will be replaced. The Recall Package is sent to all Key Markets worldwide. The Key Market of an affected country will contact the facility where these systems were installed.
Quantity in Commerce 15 subject to correction and removal
Distribution Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.
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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