FDAMay 1, 2017device
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
circadiance
Recall history
No related federal recalls on record for this brand yet.
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