Defibtech recalls DDU-2300 AEDs without Italian language instructions, violating Swiss medical device labeling laws. No action needed for safety, but ensure all three official languages are included.
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-2300 Automated External Defibrillators that lack Italian language instructions. This violates Swiss law requiring labels in all three official languages (German, French, Italian). The recall does not pose a safety risk but ensures compliance with local regulations.
Swiss law requires medical devices to have instructions in all three official languages (German, French, Italian). This recall addresses the absence of Italian translation, which could lead to non-compliance with local regulations but does not affect device safety or functionality.
Users of Defibtech DDU-2300 AEDs in Switzerland that were sold without Italian language instructions. Healthcare providers and emergency responders using these devices in Italian-speaking regions are most at risk of non-compliance.
Check for model DDU-2300 with item numbers like DCF-E2310IT (Italian language) or dual-language versions without Italian. Lot numbers listed in the recall include many specific numbers starting with 4001.
Check if the device has Italian language instructions. If not, it is part of the recall.
No, this recall is for regulatory compliance only. The AEDs are safe to use but must have instructions in all three official languages of Switzerland.
No action is required for safety, but you should ensure the device has Italian language instructions to comply with Swiss law.
DDU-2300 models with item numbers like DCF-E2310D3/1 (German/English), DCF-E2310E3/1 (German/French), DCF-E2310F3/1 (French/English), DCF-E2310G3/1 (French/German), and DCF-E2310IT (Italian).
We’ve drafted a message you can send Defibtech to request your refund or repair — edit it as you like.
Subject: Recall Z-1692-2025 — Defibtech Defibtech Hello, I own a Defibtech that is covered by recall Z-1692-2025 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.
