Class II — Defibtech, LLC
| Recalling firm | DEFIBTECH, LLC |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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). |
| 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) |
| Quantity | 13 units (OUS only) |
| Distribution | OUS only: Switzerland. |
| Initiated | 2025-03-18 |
| Classified | 2025-04-29 |
| Recall number | Z-1694-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Defibtech, LLC (Z-1694-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96653/
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