Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 brain and spine surgeries.

U.S. FDA — Device Enforcement · France · 2021-09-22 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0118-2022
Date of alert: 2021-09-22
Country / jurisdiction: France
Risk level: Class I
Risk type: recall
Brand: MEDTECH SAS
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall 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 brain and spine surgeries.

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