Class 2 Device Recall Philips SmartPath to Ingenia Elition X MR System

• Date Initiated by Firm: November 22, 2022
• Date Posted: December 08, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0461-2023
• Recall Event ID: 91195
• 510(K)Number: K173356 K173451 K183063 K193215 K213516
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
• Code Information: Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer Reason for Recall: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT Medical Device Correction Notice dated 11/22/22 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users 1. Systems that do not yet have the SmokeDetector Interlock feature installed are identified in Appendix A. If your system is listed in Appendix A immediately discontinue use of your impacted MR system(s) until Philips has installed the SmokeDetector Interlock. " Post a Do not use notice on or near the impacted MR system(s) " Post this notice near the affected MR system(s) for ease of reference. " Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. " Please complete and return the attached customer response form to Philips promptly and no later than 30 days from receipt of this letter. " Note: Once your system has the SmokeDetector Interlock installed, please follow the advice in steps 2 through 5. 2. Philips has installed a SmokeDetector Interlock feature on the systems listed in Appendix B. Immediately confirm if your system has the SmokeDetector Interlock installed by confirming your serial number is listed in Appendix B. " Post this notice near the affected MR system(s) for ease of reference. " Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. " Please complete and return the attached customer response form to Philips promptly and no later than 30 days from receipt of this letter. 3. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system (Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier: " Remove patient from the system according to the instructions for use because
• Quantity in Commerce: 566 total
• Distribution: US Nationwide.
• 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 = LNH and Original Applicant = Philips Medical Systems Nederland B.V.; 510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV; 510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland, B.V.