Recall archive / FDA device enforcement
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language)... — FDA record Z-1690-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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)
- 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).
- Classification
- Class II
- Recalling firm
- Defibtech, LLC
- Quantity
- 43 units (OUS only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1690-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International Only: Switzerland.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 7, 2025
- Recall initiation date
- Mar 18, 2025
- Center classification date
- Apr 29, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.