Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Fractional Flow Reserve (FFR) Link [UPN: H7495551000; Serial number: SPM01975].
The manufacturer initiated a removal of one FFR Link from a customer's facility following their determination that the product may have missed electrical testing during the manufacturing process.
After learning of this issue, the manufacturer's field service technician removed the unit (UPN H7495551000, serial SPM01975) for further investigation on May 15th and replaced it with a new FFR Link.
This issue resulted in no risk to patients or users of the product.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 June 2017