Dana RS Field Safety Notice

Advanced Therapeutics (UK) Ltd and Sooil Development Co., Ltd strive to meet the highest possible standard in all things we do. It is because of these high standards that Sooil Development Co., Ltd recently elected to have the cybersecurity of the Dana RS Insulin Pump evaluated by the German Intelligence Agency (BSI BUND DE).

The evaluation resulted in a possible vulnerability being reported; this possible vulnerability was detected in the isolated environment of a professional testing institution and has not been reported in the real-world.

The included Field Safety Notice describes the findings of the evaluation and actions that you can take to mitigate the risk.

A firmware update to the Dana RS Insulin Pump will soon be available that increases cybersecurity aspects of the pump and eliminates the potential vulnerability. You will be notified when this firmware update is ready and instructions on how to proceed with the update will be provided.

Please use the following links:

1) User FSN (DANA RS Cybersecurity) (002) 6 March 2020

2) 2020-03-06.User confirmation form(UK)

Please complete and return the included response form to acknowledge your receipt of this Field Safety Notice. This can be returned to us in the prepaid envelope included or you may wish to scan the completed form in to a computer and email to ourselves at info@atuk.ltd.

If you have any questions or queries please do not hesitate to contact ourselves, Advanced Therapeutics (UK) Ltd on 01926 833 273 or by email info@atuk.ltd.

Yours sincerely,

John Hughes
Managing Director