FDA recall Z-2657-2023

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-07-17

Report date

2023-10-11

Termination date

2024-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2657-2023