Defibtech recalls DDU-2200 AEDs sold in Switzerland without Italian language instructions, violating Swiss medical device regulations. Affected units lack Italian translation per Swiss Medical Devices Ordinance.
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. The recall does not pose a safety risk to users but ensures compliance with Swiss regulations.
Swiss law requires medical devices to have instructions in German, French, and Italian. The recalled AEDs only include German and English, missing Italian translation. This could lead to non-compliance with Swiss regulations but does not create a safety hazard during normal use.
Swiss consumers who own or use Defibtech DDU-2200 AEDs with German/English instructions but no Italian translation. Medical professionals using these devices in Switzerland are most at risk of non-compliance.
Check for German/English dual-language labels on the AED. The product numbers include DCF-E2210-D3/1 (German/English) or DCF-E2210-F3/1 (French/English). Lot numbers listed in the recall include 400184748, 400170814, and others.
Look for Italian language instructions on the AED. If missing, it is part of the recall.
The recall is required by Swiss law that mandates medical device instructions in all three official languages (German, French, and Italian). These AEDs only have German and English.
No safety risk exists. The hazard is regulatory non-compliance, not a risk of injury or malfunction during normal use.
Check for German/English dual-language labels and product numbers starting with DCF-E2210-D3/1 or DCF-E2210-F3/1. Lot numbers listed in the recall include 400184748, 400170814, and others.
We’ve drafted a message you can send Defibtech to request your refund or repair — edit it as you like.
Subject: Recall Z-1694-2025 — Defibtech Defibtech Hello, I own a Defibtech that is covered by recall Z-1694-2025 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.
