Caputron Brain Premier tDCS and Brain Ultimate VNS
Summary
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
Shenzhen Yingchi Technology Co., Ltd.
Block A, 2/F, Phoenix City Building, Shenzhen, Guangdong, China, 518057
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