FDA Device recall Z-1693-2025
Automated External Defibrillators, Model DDU-2450
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Automated External Defibrillators, Model DDU-2450 by Defibtech, citing 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 inst….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1693-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-18 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Defibtech |
| Distribution | n/a |
Product
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German 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).
Identifiers
| code_info | UDI-DIs: 00815098020317 (DDU-2450, export version), 10815098020314 (DDU-2450, export version (configuration level)). Lot number: 400188859. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1693-2025%22
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