[pending] Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Pending LLM rewrite. Source: FDA_DEVICE Z-1693-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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).
The recalled product
- Product
- Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
- Manufacturer
- Defibtech, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DIs: 00815098020317 (DDU-2450
- export version)
- 10815098020314 (DDU-2450
- export version (configuration level)). Lot number: 400188859.
Distribution
Distribution scope not specified by the agency.
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