Edan Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-1256-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.)

Product Classification:

Class II

Date Initiated: November 17, 2017

Date Posted: February 26, 2020

Recall Number: Z-1256-2020

Event ID: 84790

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.

Status: Terminated

Product Quantity: 7 units

Code Information:

Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002

Distribution Pattern:

U.S. Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated