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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