HIGH
FDA DEVICE
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Temperature probe devices lack FDA clearance.
Covidien
Temperature probe
Brand hub
Temperature probe devices lack FDA clearance.
Temperature probe devices lack FDA clearance.
Temperature probe devices lack FDA clearance.
Due to customer complaint regarding incorrect display box labeling.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.