Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2657-2023 — Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

U.S. FDA — Device Enforcement · United States · 2020-07-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2657-2023
Date of alert
2020-07-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Neuromodulation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000273668
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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