Class II

Medical Device Recall: Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual 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

OUS only: Switzerland.

Quantity Affected

13 units (OUS only)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1694-2025

Status: ongoing

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Defibtech, LLC Medical Device Recall: Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language) | SafeCheck