FDA recall Z-1256-2020

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2020-02-26

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2020