Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Recall
- Recall Number
- Z-3156-2024
- Event Number
- 95189
- FEI Number
- 3005075696
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 17, 2024
- Posted
- September 16, 2024
- Address
- Mazor Robotics Ltd North Industrial Park 5, Shacham Street Caesarea Israel
Description
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.
Medtronic/Mazor Robotics, Ltd. issued an URGENT: Medical Device Software Correction to its consignees on 07/17/2024 via 2-day tracked mailing. The notice explained the issue, potential risk, and provided a workaround until the software update is installed. Medtronic will schedule a time to perform a software update that will resolve these anomalies. Medtronic field service engineers will update all Mazor X systems from version 5.1.1 to version 5.1.2 or later. Questions: contact Medtronic Technical Services at 1-888-826-5603 or [email protected] .
US Nationwide distribution in PR.
94 devices