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.
