MyndMove Functional Electrical Stimulator (2015-05-05)

Starting date:

May 5, 2015

Posting date:

May 26, 2015

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-53519

• Reason
• Affected products

Recalled Products

A. MyndMove Functional Electrical Stimulator

Reason

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.

Affected products