Date Initiated by Firm |
May 15, 2020 |
Create Date |
June 26, 2020 |
Recall Status1 |
Terminated 3 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 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 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.
|