FDA Recall
Open, Classified
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Recall: Z-0101-2024
·
Initiated September 5, 2023
Recall
- Recall Number
- Z-0101-2024
- Event Number
- 93070
- FEI Number
- 3005075696
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- September 5, 2023
- Posted
- October 12, 2023
- Address
- Mazor Robotics Ltd North Industrial Park 5, Shacham Street Caesarea Israel
Description
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Reason
Software update
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.
Distribution
US Nationwide distribution.
Quantity
324 devices