Health product recall

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

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

VNS Therapy System - VNS Therapy Programming Software Model 3000 1.6

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

V1.6.1

Companies
Manufacturer

Livanova USA Inc.

100 Cyberonics Blvd.

Houston

77058

Texas

UNITED STATES