FDA Medical Device Recalls (openFDA)
Philips North America Llc: Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
- Recall number
- Z-0459-2023
- Recalling firm
- Philips North America Llc
- Product
- Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
- Status
- Open, Classified
- Initiated
- 2022-11-22
- Posted
- 2022-12-08
- Terminated
- not on file
- Reason
- Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
- Root 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
- 566 total
- Distribution
- US Nationwide.
- Lot, serial or model codes
- Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.
- 510(k) numbers
- ["K173356","K173451","K183063","K193215","K213516"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28