MEDTECH SAS Recalls
5 recalls on record · June 13, 2018 to November 3, 2021 · Medical Devices
Recalls by year
18
19
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 3, 2021Medical DevicesFDA
MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments hold
Hazard: 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 issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
February 19, 2020Medical DevicesFDA
MEDTECH SAS recalls ROSA One 3.1 Brain Application
Hazard: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
February 19, 2020Medical DevicesFDA
MEDTECH SAS recalls ROSA Brain 3.0 Application-Brain
Hazard: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
November 13, 2019Medical DevicesFDA
MEDTECH SAS recalls Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble
Hazard: The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
June 13, 2018Medical DevicesFDA
MEDTECH SAS recalls ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechani
Hazard: Replacement of units lacking an updated device approval.