Recall Z-1151-2020 ยท HAW Neurological Stereotaxic Instrument
MEDTECH SAS
ROSA One 3.1 Brain Application
| Date | Jan 6, 2020 |
| Status | Terminated |
| Reason | Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning. |
| Root cause | Software design |
| Action | On January 6, 2020, Zimmer Biomet issued URGENT MEDICAL DEVICE CORRECTION notices to customers via FedEx. Actions Required By Users: Your device can continue to be used, as long as the recommendations below are followed: While the current Instructions For Use do not require the images to be reviewed with ROSA Brain software prior to surgery, they adequately describe the standard workflow and indicate that the image acquisition of the patients head (MRI / CT or 2D X-Ray images) is performed prior to surgery, and is then loaded into the device and used by the surgeon in the preoperative pha |
| Quantity | 39 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |