Recall Atlas
Drugs & medicalClass I

MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to…

The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the…

Read the official notice →
Date
2021-11-03
Country
United States
Brand
MEDTECH SAS
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to…
Classification
Class I
Units
US Nationwide distribution and International Distribution to countries of:…
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 Details may be shortened or out of date; the official notice is the authoritative source.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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