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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical Allura Xper Systems

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 Class 2 Recall
Philips Medical Allura Xper Systems
see related information
Date Posted August 10, 2011
Recall Status1 Terminated on May 14, 2014
Recall Number Z-2976-2011
Recall Event ID 59296
Premarket Notification
510(K) Numbers
K031333  K033737  K041949 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20 The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)
Code Information Software releases: PBL 6.5.1 1PBL 6.5.2 1PBL 7.0.x 1PBL 7.2.x
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall
System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly. Please contact your local Philips representative. For further follow up please call (978 ) 687-1501.
Quantity in Commerce 1423 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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