PLEASE NOTE: AS PER HEALTH CANADA
November 22, 2010
As a valued member, iSTOP would like to keep you informed about safety issues regarding the treatment of Chronic Pain. This is to notify you that the Piezo-DX Quartz Stimulator device is currently being recalled from the Canadian market. This particular medical device has been sold in Canada since 2002.
This medical device is now being recalled by Health Canada because the manufacturer of the Piezo-DX Quartz Stimulator (ITO Company Ltd.) does not have a current Medical Device License from Health Canada.
In accordance with section 64 of the Canadian Medical Device Regulations, if you own one or more Piezo-DX Quartz Stimulators, please discontinue all clinical and/or personal usage and distribution of this particular medical device.
If you have in the past purchased this medical device from iSTOP or other suppliers for resale distribution, please contact your customers regarding this recall as instructed above.
Under the Medical Device Regulation, medical devices Classfied as I, II and III that are manufactured, imported or distributed must have the appropriate Medical Devices License.
The supplier must provide a label on the boxes to include: Name of Item of Content, Health Canada Medical Device License #, the address of the Manufacturer, Packaged and Expiry Date and Batch/Lot #.