FDAMay 17, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
What to do
FDA enforcement status: Terminated
Brands named
mediana
UPCs
46006200000246006200050146006210003346006210015018800003460066
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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