Class 2 Device Recall Philips Medical Allura Xper Systems

• Date Initiated by Firm: July 08, 2011
• Date Posted: August 10, 2011
• Recall Status: Terminated on May 14, 2014
• Recall Number: Z-2976-2011
• Recall Event ID: 59296
• 510(K)Number: 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 MA 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: 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 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; 510(K)s with Product Code = IZI