EDAN Telemetry Transmitter, Model iT20 - Product Usage: The… recallZ-1256-2020 · Edan Diagnostics · initiated Nov 17, 2017
Class II Terminated All recalls posted in February 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edan Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: No Marketing Application
What the company is doing
On 11/17/2017, the firm emailed their two Distributors and informed them of the issue and asking them to reply to email. The Recalling Firm instructed its customers/distributors to cease utilization of the affected units and offered to updated the software or have the affected products returned. For any further questions, contact USA based customer service at +1 858 750 3066.
Recall details
- Recall number
- Z-1256-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 17, 2017
- Posted by the FDA
- Feb 18, 2020
- Recalling firm
- Edan Diagnostics
- Quantity
- 7 units
- Product code
- MHX
- FDA submissions
- K161056
- Distribution
- U.S. Nationwide distribution in the state of CA.
Product description
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.)
Code information (models, lots, serial numbers)
Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
Other devices under the same FDA submission
1 device cleared under K161056 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Telemetry Transmitter iT20Edan Instruments, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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