MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
FDA device recall Z-0101-2024 · posted 2023-10-12 · Open, Classified
Recall details
- Recalling firm
- Mazor Robotics Ltd
- Reason for recall
- Software update
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 324 devices
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-09-05
- Date posted
- 2023-10-12
- Location
- Caesarea, Israel
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Mazor X (K203005) | Mazor Robotics , Ltd. | 2020-10-27 |