21
Jul
2023

FDA Recall: After Update, Software Application Not Available for Download

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Company: Medtronic Neuromodulation
Date of Enforcement Report: 07/21/2023
Class II

PRODUCT

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

Recall Number:

Z-2226-2023

REASON:

When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.

RECALLING FIRM/MANUFACTURER:

Medtronic Neuromodulation

VOLUME OF PRODUCT IN COMMERCE:

2 clinician tablets

DISTRIBUTION:

International distribution to the countries of Israel and Serbia.

About the author

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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