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VNS Therapy System — recall 61408

Health Canada — Medical Devices · Canada · 2020-06-26 · Type II

As described by Health Canada — Medical Devices: VNS Therapy System - VNS Therapy Programming Software Model 3000 1.6 (2020-06-10)

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Agency: Health Canada — Medical Devices
Recall identifier: 61408
Date of alert: 2020-06-26
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: Reason for recall is response to reports received from the field (first report received on November 11, 2019) that some M103-M106 generators are displaying a false Low Output Current Warning message upon re-interrogation operations using the M3000 software version 1.6 programmer, when the generator is actually providing stimulation as intended. Issue root cause is the software code. French translation can be found in Attachment 1.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vns-therapy-system-vns-therapy

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VNS Therapy System — recall 61408

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