Z-1256-2020Class II

EDAN Telemetry Transmitter, Model iT20 -

Name: Z-1256-2020 EDAN Telemetry Transmitter, Model iT20 -
Creator: Edan Diagnostics
Published: 2017-11-17
License: https://open.fda.gov/license/

EDAN Diagnostics, Inc. / initiated 2017-11-17 / Terminated

FDA source

Edan Diagnostics began a recall of EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments... on 2017-11-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1256-2020
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2020-02-18
Terminated: 2022-09-28
Recalling firm: EDAN Diagnostics, Inc.
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.)
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
FDA root cause: No Marketing Application
Action: 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.
Quantity in commerce: 7 units
Distribution: U.S. Nationwide distribution in the state of CA.
Product codes and lots: Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1256-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1256-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18

Product code MHX

K161056Class IITelemetry TransmitterEdan Instruments, Inc. / cleared 2017-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)