Defibtech recalls DDU-2450 AEDs sold in Switzerland without Italian language instructions, violating Swiss medical device labeling laws. Affected units must be checked for specific item numbers.
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 AEDs sold in Switzerland that lack Italian language instructions. This violates Swiss law requiring labels in three official languages. The recall does not pose a safety risk to users but ensures compliance with local regulations.
Swiss law requires medical devices to have instructions in German, French, and Italian. The recalled AEDs only include German language instructions, missing the Italian requirement. This does not create a safety hazard but violates regulatory compliance.
Swiss users of Defibtech DDU-2450 AEDs with item number DCF-E2460DE (German language) are affected. Those who use the device in Italian-speaking regions may not have complete instructions.
Check for item number DCF-E2460DE (German language) on the device. Look for lot number 400188859 or UDI-DIs 00815098020317 and 10815098020314.
Look for item number DCF-E2460DE (German language) and lot number 400188859 on the AED.
The recall is for compliance with Swiss medical device labeling laws requiring instructions in three official languages (German, French, and Italian).
No, the recall does not involve a safety risk. The missing Italian instructions do not affect device function but violate Swiss regulatory requirements.
Check for item number DCF-E2460DE (German language) and lot number 400188859 on the device.
We’ve drafted a message you can send Defibtech to request your refund or repair — edit it as you like.
Subject: Recall Z-1693-2025 — Defibtech Defibtech Hello, I own a Defibtech that is covered by recall Z-1693-2025 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.
