Reported Mar 5, 2025 · Ongoing

Brivo MR355, NMRI system

GE Healthcare (China) Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare (China) Co., Ltd. · 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area · Beijing, N/A · N/A

Is this the product you have?

  • Brivo MR355, NMRI system
Lot codes and dates
  • 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 IDs82427220047 82427240055 82427070163 82427060068 82427140137 82427010122 82427280018) (Updated 2/19/26: Additional System ID EG1736MR02)
Amount recalled
22

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.