Sep

2024

FDA Recall: Software Anomalies Leading to Screen Lagging and Incorrect Information

Allison Pate

News

fda, recall

Company: Mazor Robotics Ltd
Date of Enforcement Report: 9/16/2024
Class II

PRODUCT

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

Recall Number:

Z-3156-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Mazor Robotics Ltd

VOLUME OF PRODUCT IN COMMERCE:

94 devices

DISTRIBUTION:

US Nationwide distribution in PR.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Anomalies Leading to Screen Lagging and Incorrect Information

Allison Pate

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