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Open, Classified

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

FDA Recall Z-0101-2024 · Posted 2023-10-12

Recalling FirmMazor Robotics Ltd
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2023-09-05
Product Quantity324 devices

Reason for Recall

Software update

Firm 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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203005Mazor XMazor Robotics , Ltd. · 2020-10-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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