Recall Z-1256-2020— Edan Diagnostics
Class II · Terminated
Class II FDA medical device recall by Edan Diagnostics, initiated 2017-11-17, terminated 2022-09-28. It names one FDA 510(k) clearance: K161056. 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: 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..
- Recalling firm
- Edan Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-17
- Terminated
- 2022-09-28
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.