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Recall Observatory FDA recall evidence

Device product

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

Z-2226-2023

June 21, 2023

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 92530
Status
Ongoing
Classification
Class II
Quantity
2 clinician tablets
Official record key
device-enforcement:Z-2226-2023

Official wording

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.

Code information: Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.

Distribution pattern: International distribution to the countries of Israel and Serbia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.