Z-1240-2025Class II

Brivo MR355, NMRI system

Name: Z-1240-2025 Brivo MR355, 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 Brivo MR355, 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-1240-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-31
Posted: 2025-02-28
Recalling firm: GE Healthcare (China) Co., Ltd.
Product: Brivo MR355, 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: 22
Distribution: Domestic US distribution nationwide. International distribution worldwide.
Product codes and lots: Brivo MR355 (No UDI) System IDs 082427010096 082427020046 082427040126 082427070076 082427070077 082427070170 082427100245 082427120151 082427180030 082427210147 082427210148 082427220025 082427220045 082427230060 082427240060 082427310104 0856270058 0856270059 MRR10200 MRR9920 RU1063MR03 RU8902MR01 (Updated 12/29/25 - Additional System ID 83027805544513) (Updated 1/28/26 - Additional System IDs: 82427220047 82427240055 82427070163 82427060068 82427140137 82427010122 82427280018) (Updated 2/19/26: Additional System ID EG1736MR02)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1240-2025
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)