Recall Z-0118-2022 ยท HAW Neurological Stereotaxic Instrument
MEDTECH SAS
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.
| Date | Sep 22, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On September 22, 2021, the firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE CORRECTION" letters to affected consignees. Customers were informed of steps that may result in the issue and that should be avoided: After the registration of the patient during the ROSA One 3.1 Brain application procedure, the issue may occur when the device shuts down either manually or unexpectedly. After reboot, if the trajectory is interrupted by deactivating the pedal, the device gives the user an option to Return to HOME , Clear the robotic arm , or Continue . If the user chooses to Clear the robotic arm |
| Quantity | 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. |
| FDA record | Open on fda.gov |