Class 2 Device Recall Philips Healthcare

• Date Initiated by Firm: February 03, 2015
• Create Date: December 01, 2015
• Recall Status: Terminated on January 18, 2017
• Recall Number: Z-0348-2016
• Recall Event ID: 70370
• 510(K)Number: K033737 K041949 K130842 K971365
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Healthcare INTEGRIS cardio system Model : 722121 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: S/N: 1656 1667 1687 1668 1669 1670 1671 1685
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 978-687-1501
• Manufacturer Reason for Recall: Monitor Ceiling Suspension system may fall
• FDA Determined Cause: 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: 8 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; 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB