PlainRecalls
FDA Devices Critical Class I Ongoing

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.

Reported: November 3, 2021 Initiated: September 22, 2021 #Z-0118-2022

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
MEDTECH SAS
Units Affected
119 (US); 55 (OUS)
Distribution
US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
Location
Montpellier, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by MEDTECH SAS. Units affected: 119 (US); 55 (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Critical. Recall number: Z-0118-2022.

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