EDAN Telemetry Transmitter — Class II medical device recall Z-1256-2020
Terminated recall by Edan Diagnostics, reported 2020-02-26, distributed nationwide. Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared b
| Recall number | Z-1256-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edan Diagnostics, San Diego, CA, United States |
| Recall initiated | 2017-11-17 |
| Classified | 2020-02-18 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 7 units |
| Serial numbers | 260638-M16400850001, 260638-M17211500001, 260638-M17211500002, 260638-M17211500003, 260638-M17211500004, 261350-M17A03030001, 261350-M17A03030002 |
| Model numbers | IT20 |
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.)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1256-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.