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.)
This recall has been terminated (originally issued February 18, 2020).
- Company
- Edan Diagnostics
- Recall Initiated
- November 17, 2017
- Posted
- February 18, 2020
- Terminated
- September 28, 2022
- Recall Number
- Z-1256-2020
- Quantity
- 7 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
Root Cause
No Marketing Application
Action Taken
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.