29
Sep
2023

FDA Recall: Compatibility Issue Resulting in Inability to Communicate with Implanted Nuerostimulators

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Company: Medtronic Neuromodulation
Date of Enforcement Report: 09/29/2023
Class II

PRODUCT

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Recall Number:

Z-2657-2023

REASON:

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

RECALLING FIRM/MANUFACTURER:

Medtronic Neuromodulation

VOLUME OF PRODUCT IN COMMERCE:

2,408 devices

DISTRIBUTION:

Worldwide distribution – US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

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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