Health Canada — Medical Devices · Canada · 2015-05-26 · Type III
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Reported risk: This notice is being circulated to all users with MyndMove stimulators with serial numbers 1652014C00XX (serial number shown on label on the bottom of the stimulator) and is intended to address customer complaints related to the high frequency of falsely detected open circuit errors. When encountered, the therapy cannot be continued until the error is cleared. This may affect one or more channels. The investigation at MyndTec Inc. has determined that the root cause of this event is due to a firmware bug affecting the open circuit detection during the calibration pulses before channel set up and before starting treatment. MyndTec Inc. has corrected this problem in a new version of firmware for MyndMove stimulators with serial numbers 1652014C00XX.
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