FDA recall Z-1691-2025

Defibtech, LLC · Class II · device

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 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).

Distribution

International Only: Switzerland.

Key facts

Status
Ongoing
Initiation date
2025-03-18
Report date
2025-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guilford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2025