medical Class II Updated 2025-05-07

Defibtech, LLC recalls Semi-Automated External Defibrillators; Models: DDU-100 and

Recalled Product

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)

Hazard / Issue

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).

Issued by

FDA

Distribution: International Only: Switzerland.
Lot/Code Info: UDI-DIs: 00815098020034 (DDU-100, export version), 10815098020031 (DDU-100, export version (configuration level)). Lot numbers: 114008193, 114007350, 114007323, 114008190, 116012370, 116011831, 114006014, 114006766, 114006943, 114007067, 114007068, 114007071, 114007078, 114007091, 114007114, 114007123, 114007128, 114007137, 114007145, 114007478, 114007486, 114007517, 114007623, 114007696, 114007705, 114007770, 114007906, 114007907, 114007911, 114007914, 114007925, 114007933, 114007934, 114007964, 116011703, 116011708, 116011883, 116012476, 116012485, 116012488, 116012501, 104016266, 104016297,
View official government recall

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