Class 2 Device Recall ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES

• Date Initiated by Firm: November 24, 2021
• Create Date: March 04, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0725-2022
• Recall Event ID: 89375
• 510(K)Number: K161563 K141979
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray:; Model Number: 722031
• Code Information: S/N: OUS 109
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer Reason for Recall: Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
• FDA Determined Cause: Process control
• Action: Philips Issued Medical Device Correction letter dated 11/24/21 to U.S.A, Customers via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and action to take: Philips will inspect the affected systems for leaks and repair as required. In addition, Philips will install an extended drip tray to prevent damage from any future leaks. This service will be provided free of charge for affected systems. A Philips service representative will contact customers with affected devices to arrange for the service. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 (reference FCC 72200484).
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey United Kingdom Virgin Islands (U.S.)
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV; 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.