FDA Device Recall Z-0463-2023: Philips North America Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0463-2023.

Recall Res Number

Z-0463-2023

Recalling Firm / Manufacturer

Philips North America Llc

FEI Number

3016618143

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2022-11-22

Date Posted

2022-12-08

Date Terminated

N/A

Product Code

LNH

Event Number

91195

Product Quantity

N/A

Product Description Philips Upgrade to MR 7700 System, Model Number 782130

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

Action Details 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

Distribution Pattern US Nationwide.

Code Information / Serial Numbers Model 782120: UDI-DI: 00884838104402; Serial Numbers: 45298 45301

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Medical Device Recall: Z-0463-2023

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer