Drugs & medicalClass II

GE Healthcare (China) Co., Ltd. recalls Brivo MR355, NMRI system

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…

Read the official notice →
Date
2025-03-05
Country
United States
Brand
GE Healthcare
Product
Brivo MR355, NMRI system
Classification
Class II
Units
Domestic US distribution nationwide. International distribution worldwide.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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