Recalls / —

—#197239

Product

Philips MR 7700 System, Model Number 782120

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K173356, K173451, K183063, K193215, K213516

Affected lot / code info

Model 782120: UDI-DI: 00884838104112; Serial Numbers: 65005 65006 65007 65008

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm

Philips North America Llc

Address

222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern

US Nationwide.

Timeline

Recall initiated

2022-11-22

Posted by FDA

2022-12-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.