Medical device manufacturer, Boston Scientific Corporation, has issued a medical device safety alert concerning certain lots of LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System.
The information provided in the Portuguese Direction for Use (DFU) is incorrect. Boston Scientific has issued a customer notification communication with the corrected pages of the Portuguese DFU to ensure those users that rely on the Portuguese instructions have the correct information.
Boston Scientific clarified that all other languages are correct and no injury is expected to occur as a result of this issue.
According to the local supplier, the affected products have been distributed in Hong Kong. If you are in possession of the products, please contact your supplier for information and necessary actions.
Posted on 18 September 2012