PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 2, 2023 Initiated: June 21, 2023 #Z-2226-2023

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
2 clinician tablets
Distribution
International distribution to the countries of Israel and Serbia.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application... Recalled by Medtronic Neuromodulation. Units affected: 2 clinician tablets.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2226-2023.