Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its LATITUDE Programming System [Model Number: 3300; Part Number: 623300-103, 623300-104; Serial Number: 008885, 010823, 010615, 007886].
The Model 3300 LATITUDE Programming System is designed for remote deployment of software through WiFi or ethernet cable using the Model 3921 Software Update App. On 7 February 2020, the manufacturer released version 1.02 of this application and subsequently identified an error. The manufacturer halted remote software downloads the next day. There are four US programmers located at hospital/clinic locations that received Model 3921 v1.02 of the Software Update App. The manufacturer will remove these programmers and replace them with alternates as soon as possible.
This action affects four programmers listed that are located at US hospitals/clinics. All other Model 3300 LATITUDE Programmers may continue to be used to program implantable cardiac electronic devices.
Users are advised to segregate all the affected programmers to ensure they will not be used.
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 17 February 2020