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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Allura Xper FD10

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  Class 2 Device Recall Philips Allura Xper FD10 see related information
Date Initiated by Firm December 01, 2016
Date Posted January 20, 2017
Recall Status1 Terminated 3 on August 10, 2017
Recall Number Z-0923-2017
Recall Event ID 75845
510(K)Number K041949  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Allura Xper FD10 722026 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 783
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 1
Distribution US: WA OUS: China, Spain, Korea, Republic of, Germany
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 CO.
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