Caputron Brain Premier tDCS and Brain Ultimate VNS
Last updated
Summary
Product
Caputron Brain Premier tDCS and Brain Ultimate VNS
Issue
Medical devices - Unauthorised device
What to do
Customers will be notified and provided with the option to request a refund or return of the product.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Brain Premier tDCS | Not applicable. | C-BPE1+ |
| Brain Ultimate VNS | Not applicable. | C-BU-VNS |
Issue
U.S.-based importer (Caputron) inadvertently sold and shipped tDCS and VNS devices made in China to customers in Canada through its e-commerce website. The manufacturer and importer do not have MDEL licenses, nor does the device have an MDL license. Upon notification from Health Canada, these Class II devices are being recalled. No functional defects are identified in these devices.
Recall start date: August 21, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Shenzhen Yingchi Technology Co., Ltd.
Block A, 2/F, Phoenix City Building, Shenzhen, Guangdong, China, 518057
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-78050
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