Class II

Medical Device Recall: Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

Defibtech, LLC · March 18, 2025

Reason for Recall

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).

Distribution

International Only: Switzerland.

Quantity Affected

43 units (OUS only)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1690-2025

Status: ongoing

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Defibtech, LLC Medical Device Recall: Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language) | SafeCheck