Date Initiated by Firm | November 03, 2015 |
Date Posted | February 05, 2016 |
Recall Status1 |
Terminated 3 on August 19, 2016 |
Recall Number | Z-0765-2016 |
Recall Event ID |
72571 |
510(K)Number | K102005 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. |
Code Information |
Ceiling version only. |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
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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 | 2 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 |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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