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.)
FDA Recall Z-1256-2020 · Posted 2020-02-18
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Recalling FirmEdan Diagnostics
Recall StatusTerminated
Product CodeMHX
Date Initiated2017-11-17
Date Terminated2022-09-28
Product Quantity7 units
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.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
U.S. Nationwide distribution in the state of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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