CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report

Optima MR360, NMRI system recalled by GE Healthcare (China) Co

GE Healthcare (China) is recalling Optima MR360, NMRI system, distributed nationwide in the US. The recall was initiated on 31 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs 082427040134 082427040185 082427060043 082427070088 082427070093 082427070099 082427100174 082427100178 082427100197 082427120140 082427140095 082427220046 082427270041 082427310088 082427310092 083027288790310 0856270061 AE1373MR01 DZ1339MR03 FI1432MR01 H4678MR04 MRR9282 MRR9877 PL2059MR01 PL2433MR01 RU3338MR03 SA1056MR03 SA2191MR04 SA2253MR01 SA2352MR01 TN1008MR01 TN1241MR01 34352MRS01 (Update 12/29/25 - Additional System IDs 83027809699615, LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)

Quantity recalled33

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-1241-2025
FDA event ID: 96311
Recalling firm: GE Healthcare (China), Beijing, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jan 2025
FDA classified: 27 Feb 2025
Reported: 5 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

31 Jan 2025	Recall initiated by company
27 Feb 2025	Classified by FDA	+27 days
5 Mar 2025	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

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

Product as listed by the FDA

Optima MR360, NMRI system

Where it was distributed

Domestic US distribution nationwide. International distribution worldwide.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

A. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs 082427040134 082427040185 082427060043 082427070088 082427070093 082427070099 082427100174 082427100178 082427100197 082427120140 082427140095 082427220046 082427270041 082427310088 082427310092 083027288790310 0856270061 AE1373MR01 DZ1339MR03 FI1432MR01 H4678MR04 MRR9282 MRR9877 PL2059MR01 PL2433MR01 RU3338MR03 SA1056MR03 SA2191MR04 SA2253MR01 SA2352MR01 TN1008MR01 TN1241MR01 34352MRS01 (Update 12/29/25 - Additional System IDs 83027809699615, LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)

Where was it sold?

Domestic US distribution nationwide. International distribution worldwide.

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

Other products in this recall event

4 other products · FDA event 96311

This product is part of a recall event; the main page for the event is Brivo MR355, NMRI system recalled by GE Healthcare (China) Co.

Reported	Class	Recall	Company	Reason	Where
5 Mar 2025	CLASS II	Brivo MR355, NMRI system recalled by GE Healthcare (China) Co	GE Healthcare (China)	Other	Nationwide
5 Mar 2025	CLASS II	Signa Creator, Signa Explorer, Nmri systems recalled	GE Healthcare (China)	Other	Nationwide
5 Mar 2025	CLASS II	Signa MR355, Signa MR360, Nmri system recalled	GE Healthcare (China)	Other	Nationwide
5 Mar 2025	CLASS II	Signa MR380, Nmri system, Non-US Only recalled	GE Healthcare (China)	Other	Nationwide

More recalls from GE Healthcare (China)

All 24

Reported	Class	Recall	Company	Reason	Where
5 Mar 2025Device	CLASS II	Signa MR380, Nmri system, Non-US Only recalled	GE Healthcare (China)	Other	Nationwide
5 Mar 2025Device	CLASS II	Signa MR355, Signa MR360, Nmri system recalled	GE Healthcare (China)	Other	Nationwide
5 Mar 2025Device	CLASS II	Signa Creator, Signa Explorer, Nmri systems recalled	GE Healthcare (China)	Other	Nationwide
5 Mar 2025Device	CLASS II	Brivo MR355, NMRI system recalled by GE Healthcare (China) Co	GE Healthcare (China)	Other	Nationwide
11 Dec 2024Device	CLASS II	GE Healthcare Operator Console Upgrade Types recalled	GE Healthcare (China)	Packaging Defects

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All 2,336

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