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.
