Reported Jul 28, 2021 · Terminated
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP),…
Mediana Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mediana Co., Ltd. · 132 Donghwagongdan-Ro · Wonju, N/A · N/A
Is this the product you have?
- 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 codes and dates
- Serial #(s) 460062000002 thru 460062000501
- and 460062100033 thru 460062100150 UDI(01)18800003460066
- Amount recalled
- 618
Where it was sold
Why it was recalled
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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