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U.S. Department of Health and Human Services

Class 2 Device Recall Vital Signs Monitor

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 Class 2 Device Recall Vital Signs Monitorsee related information
Date Initiated by FirmMay 17, 2021
Create DateJuly 19, 2021
Recall Status1 Terminated 3 on November 04, 2022
Recall NumberZ-2096-2021
Recall Event ID 88166
510(K)NumberK200434 
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
ProductAVSM3 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/
Manufacturer		 Mediana Co., Ltd.
132 Donghwagongdan-Ro
Munmag-Eup
Wonju Korea (the Republic of)
For Additional Information ContactJason Kim
425-4062262
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
ActionThe 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 Commerce618
DistributionUS Distribution to: Wisconsin only
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXN
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