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Open, Classified

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

FDA Recall Z-0461-2023 · Posted 2022-12-08

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2022-11-22
Product Quantity566 total

Reason for Recall

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

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

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V. · 2022-03-03K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2020-04-10K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019-02-14K173451Ingenia Elition S and Ingenia Elition XPhilips Medical Systems Nederland B.V. · 2018-03-20K173356Ingenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V. · 2018-03-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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