Montpellier, N/A, France
MEDTECH SAS recalls
4 recalls recorded since 2018, most recently on 22 September 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 22 September 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0118-2022
- 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 brai
Terminated Class II Medical devices
- Recall started
- 6 January 2020
- Terminated
- 5 November 2020
- Reason
- 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.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1150-2020, Z-1151-2020
- ROSA Brain 3.0 Application-Brain
- ROSA One 3.1 Brain Application
Terminated Class I Medical devices
- Recall started
- 10 September 2019
- Terminated
- 2 November 2021
- Reason
- 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.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0172-2020
- 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
Terminated Class II Medical devices
- Recall started
- 8 May 2018
- Terminated
- 19 August 2020
- Reason
- Replacement of units lacking an updated device approval.
- Distribution
- US Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2108-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.