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Recall Observatory FDA recall evidence

Device product

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

Z-2657-2023

July 17, 2020

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 92798
Status
Terminated
Classification
Class II
Quantity
2,408 devices
Official record key
device-enforcement:Z-2657-2023

Official wording

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.

Code information: Version 1.0.4232, UDI-DI 00763000273668.

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    issue with some legacy clinician programmer software