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U.S. Department of Health and Human Services

Class 2 Device Recall DIRECT SUPPLY Attendant VITAL SIGNS MONITOR

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  Class 2 Device Recall DIRECT SUPPLY Attendant VITAL SIGNS MONITOR see related information
Date Initiated by Firm May 15, 2020
Create Date June 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-2441-2020
Recall Event ID 85685
510(K)Number K170497  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Code Information Serial Numbers: 456802000001~456802000180
Recalling Firm/
Manufacturer
Mediana Co., Ltd.
132 Donghwagongdan-Ro
Munmag-Eup
Wonju Korea (the Republic of)
Manufacturer Reason
for Recall
Failures were found in the temperature measurement function while in the predict mode.
FDA Determined
Cause 2
Process change control
Action The firm notified their sole consignee on 05/15/2020 by email. The device is being recalled to the user level.
Quantity in Commerce 180 devices
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = Mediana Co., Ltd.
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