Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its 4G LATITUDE MIMIC Cell Adapter [Universal Part Number: 666227-100; BSC Model: 6227; Serial Number: Multiple; GTIN: 00802526615207; Supplier Model: TD191]

The manufacturer has identified that up to 3,413 of these Cell Adapters distributed in some countries in Europe, were configured incorrectly by the manufacturer and will not allow the LATITUDE System to connect to a 4G cellular network. According to the manufacturer, this Cell Adapter behavior neither affects data security nor the integrity of the Communicator.

If an incorrectly configured Cell Adapter is connected to a Communicator, it will not connect to the system in the following situations:

• If data transmission is unsuccessful connecting to the LATITUDE System, the Communicator will display one yellow sending wave.
• If a Cardiac Implantable Electronic Device (CIED) alert condition is not transmitted, the Communicator will display a Red Call Doctor icon.
• If the Communicator is unable to transmit data to the LATITUDE System, the Health Care Professional will be informed via LATITUDE after 14 days.

The manufacturer is notifying users that they can contact them for Replacement Cell Adapters with the correct configuration. Users are also advised to immediately segregate all affected products and dispose them locally.

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 8 February 2021