Z-1256-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- November 17, 2017
- Termination Date
- September 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.)
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 Pattern
U.S. Nationwide distribution in the state of CA.
Code Information
Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002