Class 2 Device Recall DIRECT SUPPLY Attendant VITAL SIGNS MONITOR

• Date Initiated by Firm: May 15, 2020
• Create Date: June 26, 2020
• Recall Status: Terminated on September 16, 2022
• 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: 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 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 = DXN