Recall Z-0101-2024 ยท OLO Orthopedic Stereotaxic Instrument
Mazor Robotics Ltd
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
| Date | Oct 12, 2023 (initiated Sep 5, 2023) |
| Status | Open, Classified |
| Reason | Software update |
| Root cause | Software design |
| Action | IMazor Robotics, Ltd. issued an URGENT: Medical Devices Software Correction notice to its consignees on 09/05/2023 via 2-day tracked mailing and in Puerto Rico it was hand delivered by the regional field representative. The notice explained the anomalies to be corrected and the potential health hazards associated with the anomalies. Medtronic field service engineers will be updating all Mazor X" systems from version 4.2.2 or 5.0.1 to version 5.1.1 in the US at your next planned service visit, or earlier. |
| Quantity | 324 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203005 | Mazor X Mazor Robotics , Ltd., Oct 27, 2020 |