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Recall Observatory FDA recall evidence

Device product

Clinician Programmer Application (CPA) model A610 Clinician Software Application

Z-0201-2022

September 23, 2021

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 88761
Status
Ongoing
Classification
Class II
Quantity
3302
Official record key
device-enforcement:Z-0201-2022

Official wording

Reason: A software anomaly may occur with the clinician programmer application.

Code information: Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly