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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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  Class 2 Device Recall Philips Healthcare see related information
Date Initiated by Firm February 03, 2015
Create Date December 01, 2015
Recall Status1 Terminated 3 on January 18, 2017
Recall Number Z-0346-2016
Recall Event ID 70370
510(K)Number K041949  K033737  K130842  K971365  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Philips Healthcare Allura Xper Series:
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD21
Allura Xper FD22
Allura Xper FD23
Allura Xper FD24
Allura Xper FD25

Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Code Information System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xper FD10/10 722012 1951 Allura Xper FD20 722012 536 Allura Xper FD21 722012 504 Allura Xper FD22 722012 748 Allura Xper FD23 722012 536 Allura Xper FD24 722012 579 Allura Xper FD25 
Recalling Firm/
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
Monitor Ceiling Suspension system may fall
FDA Determined
Cause 2
Process control
Action Philips sent an Urgent Field Safety Notice letter dated January 8, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The actuator of all affected systems will be replaced free of charge. All affected customers will be contacted in order to schedule the implementation of this action. For questions contact your local Philips representatice: Technical Support Line: 1-800-722-9377.
Quantity in Commerce 9 units
Distribution Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
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 NEDERLAND B.V.
510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.