June 14, 2017Medical DevicesFDA
Circadiance LLC recalls SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, he
Hazard: Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.