Recall – Spatial positioning app causes inaccurate electrode placement

Company: MEDTECH SAS
Date of Enforcement Report: 11/3/2021
Class I

PRODUCT

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.

Recall Number: Z-0118-2022

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.

RECALLING FIRM/MANUFACTURER

MEDTECH SAS on 9/22/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

119 (US); 55 (OUS)

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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