MEDTECH SAS

5 recalls •

• Categories: Surgical Instruments, Other Medical Devices, Implants & Prosthetics, Diagnostic Equipment

ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

Class I - Dangerous

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.

Sep 22, 2021 Surgical Instruments Nationwide View Details →

ROSA Brain 3.0 Application-Brain

Class I - Dangerous

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.

Jan 6, 2020 Other Medical Devices Nationwide View Details →

ROSA One 3.1 Brain Application

Class I - Dangerous

Jan 6, 2020 Other Medical Devices Nationwide View Details →

Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

Class I - Dangerous

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.

Sep 10, 2019 Implants & Prosthetics Nationwide View Details →

ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Class I - Dangerous

Replacement of units lacking an updated device approval.

May 8, 2018 Diagnostic Equipment View Details →