Z-1241-2025Class II

Optima MR360, NMRI system

Name: Z-1241-2025 Optima MR360, NMRI system
Creator: GE Healthcare (China) Co., Ltd.
Published: 2025-01-31
License: https://open.fda.gov/license/

GE Healthcare (China) Co., Ltd. / initiated 2025-01-31 / Open, Classified / root cause: software

FDA source

GE Healthcare (China) Co., Ltd. began a recall of Optima MR360, NMRI system on 2025-01-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1241-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-31
Posted: 2025-02-28
Recalling firm: GE Healthcare (China) Co., Ltd.
Product: Optima MR360, NMRI system
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: software
FDA root cause: Software design
Action: On January 31, 2025, the firm notified customers through Urgent Medical Device Correction letters. Customers were provided with instructions for continued use of their MR systems. All potential users should be made aware of this safety notification and recommended actions. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 33
Distribution: Domestic US distribution nationwide. International distribution worldwide.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1241-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27
Z-1240-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27
Z-1241-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27
Z-1242-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27
Z-1243-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27

Product code LNH

K123417Class IIBrivo Mr355, Optima Mr360Ge Hangwei Medical Systems Co., Ltd. / cleared 2013-01-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)