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Health product recall

Transcranial direct current stimulation and SmartStim TDCS (2014-08-18)

Starting date:
August 18, 2014
Posting date:
October 27, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41881

Recalled Products   

A) Transcranial direct current stimulation
B) SmartStim TDCS

Reason

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.

Affected products

A) Transcranial direct current stimulation
 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

200

Companies
Manufacturer
Nuraleve Inc. also operating as Nordocs Technologies
1-2280 Carling Avenue,
Ottawa
K2B 7G1
Ontario
CANADA

B) SmartStim TDCS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

200

Companies
Manufacturer
Nuraleve Inc. also operating as Nordocs Technologies
1-2280 Carling Avenue,
Ottawa
K2B 7G1
Ontario
CANADA