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Recall Observatory FDA recall evidence

Device 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)

Z-1690-2025

March 18, 2025

Class II

Product summary

Firm
Defibtech, LLC
Event
Event 96618
Status
Ongoing
Classification
Class II
Quantity
43 units (OUS only)
Official record key
device-enforcement:Z-1690-2025

Official wording

Reason: 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).

Code information: 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,

Distribution pattern: International Only: Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).