Recall Z-0118-2022— MEDTECH SAS
Class I · Ongoing
Class I FDA medical device recall by MEDTECH SAS, initiated 2021-09-22. It names 2 FDA 510(k) clearances: K200511, K182417. 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.. 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
- MEDTECH SAS
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-09-22
- Firm location
- Montpellier, N/A, France
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.