Date Initiated by Firm | December 01, 2016 |
Date Posted | January 20, 2017 |
Recall Status1 |
Terminated 3 on August 10, 2017 |
Recall Number | Z-0925-2017 |
Recall Event ID |
75845 |
510(K)Number | K133292 |
Product Classification |
Interventional Fluoroscopic X-Ray System - Product Code OWB
|
Product | Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP). |
Code Information |
159, 183 |
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 | Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled. |
FDA Determined Cause 2 | Process control |
Action | Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take. |
Quantity in Commerce | 2 |
Distribution | US: WA
OUS: China, Spain, Korea, Republic of, Germany |
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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