VNS Therapy System - VNS Therapy Programming Software Model 3000 1.6 (2020-06-10)

Starting date:

June 10, 2020

Posting date:

June 26, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73431

Last updated: 2020-06-29

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  Reason
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  Affected products

Affected Products

VNS Therapy System - VNS Therapy Programming Software Model 3000 1.6

Reason

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.

Affected products