Defibtech recalls DDU-2200 AEDs sold in Switzerland without Italian language instructions, violating Swiss medical device regulations requiring three official languages.
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 certain DDU-2200 Automated External Defibrillators sold in Switzerland that lack Italian language instructions. This violates Swiss law requiring product information in all three official languages (German, French, and Italian).
Swiss medical device regulations require product labels and instructions in all three official languages. This AED model was only provided in German/English or French/English, missing the required Italian translation. Without Italian instructions, users in Italian-speaking regions may not understand critical safety steps during emergencies.
Swiss users of Defibtech DDU-2200 AEDs with German/English or French/English dual-language models. Those who need Italian language instructions for medical emergencies are at slightly higher risk.
Check for German/English or French/English dual-language labels on the AED. Look for lot numbers: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, 400149090.
Look for Italian language instructions on the AED. If missing, the device is part of the recall.
The AEDs were sold in Switzerland without Italian language instructions, violating Swiss law that requires product information in all three official languages (German, French, and Italian).
No, the recall does not require stopping use. The issue is a language translation omission, not a safety hazard.
Check for German/English or French/English dual-language labels and verify the 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-1691-2025 — Defibtech Defibtech Hello, I own a Defibtech that is covered by recall Z-1691-2025 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.
