Important Safety Information

 PSS Unnoticed Leak at MEDUMAT Standard²

FSCA MMS2 2026-05.01_ PSSUnnoticedLeak 

Quality and safety are our top priorities, which is why we want to act consistently and transparently as usual and kindly request that you implement this Field Safety Corrective Action as part of your duty to cooperate in accordance with medical device legislation, so that users can continue to use our products safely on patients.

What you as a user, operator, or specialist dealer must do in the next step:

1. Read the safety notice 
You can download this notice in your official language below. Please read the safety notice in full and follow the instructions given.

2. Send us your reply
Receipt of the safety notice must be confirmed using the reply form.

3. Implement the measures
Implement the measures specified in the safety notice promptly. This Field Safety Corrective Action is a compulsory measure. The responsible authority has been notified accordingly.

You can download the safety notice in your national language here: 

Please confirm receipt of this notice here:

To the Reply form

Additions to the instructions for use

You can find supplements to the instructions for use for MEDUMAT Standard² here:
Download

Notice for ambulance stations

As an additional service for your employees, we offer you a notice for ambulance stations. You can download it in the following languages:

Do you have any questions or require assistance?

If you have any questions, or need assistance, please contact your local specialist dealer or contact us directly: