Recall Z-1691-2025— Defibtech, LLC
Class II · Ongoing
Class II FDA medical device recall by Defibtech, LLC, initiated 2025-03-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual 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)..
- Recalling firm
- Defibtech, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-18
- Firm location
- Guilford, CT, United States
Product description
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.