FDAMarch 18, 2025device
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Ongoing
Brands named
defibtech
UPCs
0081509802023210815098020239
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAutomated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)2025-03-18
- FDAAutomated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)2025-03-18
- FDAAutomated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)2025-03-18
- FDASemi-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)2025-03-18
- FDADefibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)2024-10-14
- FDADefibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)2024-10-14
- FDADefibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)2024-10-14
- FDADefibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)2024-10-14
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