Circadiance LLC recalls SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, hear…

Recall date

May 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2250-2017

FDA classification

Class II

Brand / firm

Circadiance LLC

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.