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U.S. Department of Health and Human Services

Class 2 Device Recall EDAN Telemetry Transmitter, Model iT20

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  Class 2 Device Recall EDAN Telemetry Transmitter, Model iT20 see related information
Date Initiated by Firm November 17, 2017
Date Posted February 18, 2020
Recall Status1 Terminated 3 on September 28, 2022
Recall Number Z-1256-2020
Recall Event ID 84790
510(K)Number K161056  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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.)
Code Information Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
Recalling Firm/
Manufacturer
Edan Diagnostics
9833 Pacific Heights Blvd
San Diego CA 92121-4707
For Additional Information Contact Chao Lin
858-750-3066
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 7 units
Distribution U.S. Nationwide distribution in the state of CA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = Edan Instruments, Inc.
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