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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Allura Xper FD20 R8.2 722028

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 Class 2 Device Recall Philips Allura Xper FD20 R8.2 722028see related information
Date Initiated by FirmDecember 01, 2016
Date PostedJanuary 20, 2017
Recall Status1 Terminated 3 on August 10, 2017
Recall NumberZ-0924-2017
Recall Event ID 75845
510(K)NumberK133292 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductAllura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
Code Information 1000
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
ActionCustomers 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 Commerce2
DistributionUS: WA OUS: China, Spain, Korea, Republic of, Germany
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
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