Z-0463-2023Class II

Philips Upgrade to MR 7700 System, Model Number 782130

Name: Z-0463-2023 Philips Upgrade to MR 7700 System, Model Number 782130
Creator: Philips North America Llc
Published: 2022-11-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-11-22 / Open, Classified

FDA source

Philips North America Llc began a recall of Philips Upgrade to MR 7700 System, Model Number 782130 on 2022-11-22. FDA classified it as Class II and gives the reason as "Gradient Coil may act as a heat source with a potential to produce smoke and/or fire". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0463-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-22
Posted: 2022-12-08
Recalling firm: Philips North America LLC
Product: Philips Upgrade to MR 7700 System, Model Number 782130
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
FDA 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
Distribution: US Nationwide.
Product codes and lots: Model 782120: UDI-DI: 00884838104402; Serial Numbers: 45298 45301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0459-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08
Z-0460-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08
Z-0461-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08
Z-0462-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08
Z-0463-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)