FDA-Device2017-06-14Class II
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.
Circadiance LLC
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.
Sold states
Nationwide Distribution.
Affected count
1,242 units
Manufactured in
1060 Corporate Ln, N/A, Export, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2017Don't want to check this manually?
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