Class II — Edan Diagnostics
| Recalling firm | EDAN Diagnostics, Inc. |
|---|---|
| Registered facility | EDAN Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA. |
| Product | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.) |
| Quantity | 7 units |
| Distribution | U.S. Nationwide distribution in the state of CA. |
| Initiated | 2017-11-17 |
| Classified | 2020-02-18 |
| Terminated | 2022-09-28 |
| Recall number | Z-1256-2020 |
| 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 — Edan Diagnostics (Z-1256-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84790/
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