FDA recall Z-2226-2023

Product

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.

Distribution

International distribution to the countries of Israel and Serbia.

Key facts

Status

Ongoing

Initiation date

2023-06-21

Report date

2023-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2226-2023