Product Wiki · Recalls · Health Canada — Medical Devices

Activa PC+S Implantable Neurostimulator (INS) (2018-08-29) — recall 58392

Health Canada — Medical Devices · Canada · 2018-09-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58392
Date of alert
2018-09-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Manufacturer identified anomaly in the Activa PC+S firmware. This anomaly can result in a Model 37604 Activa PC+S Implantable Neurostimulator (INS) that cannot communicate with programming instruments, such as the Model 37642 patient programmer or Model 8840 clinician programmer. The issue also affects Activa PC+S devices that have been updated with the investigational nexus-e firmware.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/activa-pcs-implantable-neurost

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