Product Wiki · Recalls · Health Canada — Medical Devices

Transcranial direct current stimulation and SmartStim TDCS… — recall 52184

Health Canada — Medical Devices · Canada · 2014-10-27 · Type III

As described by Health Canada — Medical Devices: Transcranial direct current stimulation and SmartStim TDCS (2014-08-18)

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Agency
Health Canada — Medical Devices
Recall identifier
52184
Date of alert
2014-10-27
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: A single computer connected to more than one SmartStim model 200 device. In some instances, as in the case with computers with slower/less powerful CPUs, this presented a problem. When more than a single device was connected to a single pc, what could happen is that the connection would drop, causing the TDCs stimulation to stop. There is a mild risk of seeing a flash of light, because of the abrupt interruption of the stimulation otherwise no injuries could occur in such a scenario.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/transcranial-direct-current-st

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