Defibtech recalls DDU-100 and DDU-100E defibrillators due to missing Italian language instructions, violating Swiss medical device labeling requirements.
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Defibtech is recalling its DDU-100 and DDU-100E semi-automated external defibrillators because they lack Italian language instructions. This violates Swiss law requiring product information in all three official languages. The recall affects specific model numbers and lot numbers listed in the official notice.
Swiss law requires medical devices to have instructions in German, French, and Italian. This defibrillator only includes German and French language instructions, missing the Italian version. Without Italian instructions, users in Italian-speaking regions may not understand how to operate the device during emergencies.
Owners of Defibtech DDU-100 and DDU-100E defibrillators with the listed model numbers and lot numbers are affected. Emergency responders and individuals with these devices at home or in public spaces are most at risk if they need to use the device in Italian-speaking areas.
Check for model numbers DDU-100 or DDU-100E with item numbers starting with DCF-E110SG-DE/1 (German) or DCF-E110SG-FR/1 (French). The affected devices have specific lot numbers listed in the recall notice.
Verify if your defibrillator has Italian language instructions on the label or manual.
The recall is because the defibrillator lacks Italian language instructions, violating Swiss law that requires product information in all three official languages (German, French, and Italian).
No action is needed if your defibrillator includes Italian language instructions as required by Swiss law.
The affected models are DDU-100 and DDU-100E with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Defibtech to request your refund or repair — edit it as you like.
Subject: Recall Z-1690-2025 — Defibtech Defibtech Hello, I own a Defibtech that is covered by recall Z-1690-2025 from Defibtech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
