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.)
Recall
- Recall Number
- Z-1256-2020
- Event Number
- 84790
- Firm
- Edan Diagnostics
- FEI Number
- 3009499478
- Product Code
- MHX
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- November 17, 2017
- Posted
- February 18, 2020
- Terminated
- September 28, 2022
- Address
- 9833 Pacific Heights Blvd, San Diego, CA, 92121-4707
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.)
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.
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.
U.S. Nationwide distribution in the state of CA.
7 units