Boston Scientific has issued a medical device safety alert concerning its AUTOLITH TOUCH EHL [UPN: M005466800, GTIN/UDI: 00817183020493, Serial Numbers: All distributed prior to 15-November-2021].
The manufacturer initiated a product advisory due to a recently identified discrepancy in some languages. When Russian, Romanian, Slovak, and Czech are selected, the device text will indicate high power (but operate in low power) and the text will indicate low power (but operate on high power):
According to the manufacturer, the differences between high and low power do not impact patient safety. It also mentions that the text displays as intended in all other languages and there have been no reported adverse events associated with this issue. The manufacturer recommends that this information should be known to all users of this device.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Dec 2021