Class 2 Device Recall Philips

• Date Initiated by Firm: December 01, 2016
• Date Posted: January 20, 2017
• Recall Status: Terminated on August 10, 2017
• Recall Number: Z-0925-2017
• Recall Event ID: 75845
• 510(K)Number: K133292
• Product Classification: Interventional Fluoroscopic X-Ray System - Product Code OWB
• Product: Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
• Code Information: 159, 183
• 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: Process control
• Action: Customers 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 Commerce: 2
• Distribution: US: WA OUS: China, Spain, Korea, Republic of, Germany
• 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.