• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Vital Signs Monitor

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Vital Signs Monitor see related information
Date Initiated by Firm May 17, 2021
Create Date July 19, 2021
Recall Status1 Terminated 3 on November 04, 2022
Recall Number Z-2096-2021
Recall Event ID 88166
510(K)Number K200434  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product AVSM3 SNF, Vital Signs Monitor

The monitor is intended to be used 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 #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150  UDI:(01)18800003460066
Recalling Firm/
Mediana Co., Ltd.
132 Donghwagongdan-Ro
Wonju Korea (the Republic of)
For Additional Information Contact Jason Kim
Manufacturer Reason
for Recall
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm sent a "URGENT : Field Safety Notice(Correction)" email dated May 17, 2021 to its consignee. The email describes the product, problem and actions to be taken. The following actions were to be implemented: Implementation of action plan (1) Inventory stock a importer's hand: Mediana service engineer will update before ship to end users. (2) The products at end user's hand: Provide the modified new Software via USB memory stick and instruction for upgrading the S/W 3. Required actions for the user - INSPECT the inventory for the affected Model number, serial number(s), and date of manufacture. - IF USER HAVE affected devices Contact Customer Technical Services or Sales Representative for correction. - RETURN the enclosed acknowledgement form to Mediana USA service center. - UPGRADE THE S/W with the received s/w according to the instruction. - IF ANY Problem occurred during the upgrade Contact Customer Technical Services or Sales Representative. If you have any questions, contact QMS Representative at +82 70 7092 9945; email: don@mediana.co.kr. or Sales Representative at +82 70 7092 9525; email: chris.shin@mediana.co.kr. or Technical Services at 425-406-2262; email: Jason.kim@medianausa.com.
Quantity in Commerce 618
Distribution US Distribution to: Wisconsin only
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 and Original Applicant = Mediana Co., Ltd.