CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report

Philips MR 7700 System recalled by Philips North America

Philips North America is recalling Philips MR 7700 System, distributed nationwide in the US. The recall was initiated on 22 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 782120: UDI-DI: 00884838104112; Serial Numbers: 65005 65006 65007 65008

Quantity recalled566 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0462-2023
FDA event ID: 91195
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Nov 2022
FDA classified: 8 Dec 2022
Reported: 14 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Nov 2022	Recall initiated by company
8 Dec 2022	Classified by FDA	+16 days
14 Dec 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Philips MR 7700 System, Model Number 782120

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Is Philips MR 7700 System recalled?

Yes. Philips North America recalled Philips MR 7700 System on 22 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0462-2023.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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