Kinesia ONE and Kinesia 360
Brand(s)
Last updated
Summary
Product
Kinesia ONE and Kinesia 360
Issue
Medical devices - Unauthorised device
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Kinesia ONE |
Not applicable. |
700-0019 |
Kinesia 360 |
Not applicable. |
700-0020 |
Issue
The Kinesia ONE and Kinesia 360 products are being recalled because they were incorrectly sold as class I devices but should have been classified as class II devices, and thus do not have valid Medical Device Licenses (MDL).
Recall Start Date: March 28, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Great Lakes Neurotechnologies Inc.
6100 Rockside Woods Blvd N, Cleveland, Ohio, United States, 44131
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77312
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