Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its EXALT Controller [UPN #: M00542430; Serial Number: 2005201213, 2005201287, 2005201346; Date of Manufacture: 2 Nov 2020, 3 Nov 2020, 4 Nov 2020].
The manufacturer is initiating a voluntary removal of specific EXALT Controllers. Following an investigation by the manufacturer, three Controllers were identified as units that may have been programmed with a less than optimal brightness setting. This could result in a darker than desired image. While no adverse health consequences are anticipated and an impacted Controller can continue to be used, replacement of the Controller is advised for optimal image quality.
The manufacturer advised that if users notice a darker than desired image, manually adjust the brightness setting on the front of the EXALT Controller to the "High" setting (all five bars on the Brightness Indicator illuminated).
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 16 March 2021