GE Healthcare (China) Co., Ltd. 2025-03-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1240-2025
Brivo MR355, NMRI system Recall
Issued March 5, 2025 · GE Healthcare (China) Co., Ltd.
In March 2025, GE Healthcare (China) Co., Ltd. recalled the Brivo MR355, NMRI system, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brivo MR355, NMRI system right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Healthcare (China) Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Healthcare (China) Co., Ltd.
- Category
- Health
- Recall date
- March 5, 2025
- Units affected
- Not reported
- Sold at
- Domestic US distribution nationwide. International distribution worldwide.
- Recall number
- FDA-Z-1240-2025
- Made in
- China
- Issuing agency
- FDA
In context
- GE Healthcare (China) Co., Ltd. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.