AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), funct
Summary
The FDA issued a Class II for AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor by Mediana Co., Ltd.. Reason: In some cases the equipment fails to power up and/or key or button unresponsive or not working..
Details
Source
Device Recall
External ID
Z-2096-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066
Quantity Affected: 618
Reason for Recall
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Distribution
US Distribution to: Wisconsin only
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-17
Company
Wonju, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mediana Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mediana Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Mediana Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2096-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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