GE Healthcare (China) Co., Ltd.: Medical Device Recall in 2025 - (Recall #: Z-1240-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brivo MR355, NMRI system

Product Classification:

Class II

Date Initiated: January 31, 2025

Date Posted: March 5, 2025

Recall Number: Z-1240-2025

Event ID: 96311

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.

Status: Ongoing

Product Quantity: 22

Code Information:

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)

Distribution Pattern:

Domestic US distribution nationwide. International distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated