Recall Z-1256-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Edan Diagnostics
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.)
| Date | Feb 18, 2020 (initiated Nov 17, 2017) |
| Status | Terminated |
| 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. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 7 units |
| Distribution | U.S. Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161056 | Telemetry Transmitter Edan Instruments, Inc., Feb 3, 2017 |