Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Zoom LATITUDE Programmer. The affected products are identified as follow:
The manufacturer is retrieving four affected products due to an improper software configuration for certain older pulse generator families, which have not been distributed for over 5 years. The improper software configuration was identified during an internal inspection process.
According to the manufacturer, there is no patient risk and no patient harm has been reported to date or is likely to occur.
Customers are advised to segregate the affected products to ensure that they will not be used.
Product removal and replacement are on-going.
Once the manufacturer completes the removal, it will start the process to perform a factory update on the affected products.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 23 August 2019