FDAMay 15, 2020device
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 an...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failures were found in the temperature measurement function while in the predict mode.
What to do
FDA enforcement status: Terminated
Brands named
mediana
UPCs
456802000001456802000180
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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