Defibtech, LLC is recalling several models of Automated External Defibrillators (AEDs), including the DDU-100, DDU-100E, DDU-2200, DDU-2300, and DDU-2450, because they were distributed in Switzerland without Italian language instructions and labeling. Approximately 269 units are affected by this recall. The missing translations are required by Swiss regulations to ensure all official languages of Switzerland—German, French, and Italian—are provided for medical devices. No incidents or injuries have been reported to date.
The lack of Italian language instructions could prevent an Italian-speaking user from correctly operating the AED during a life-threatening cardiac emergency. This could lead to a delay in treatment or improper use of the device, increasing the risk of patient harm.
Recall #: Z-1690-2025
Recall #: Z-1691-2025
Recall #: Z-1692-2025
Recall #: Z-1693-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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