Company: Circadiance LLC
Date of Enforcement Report 6/14/2017
Class lI:
PRODUCT
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
Recall Number Z-2250-2017
REASON
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
RECALLING FIRM/MANUFACTURER
Circadiance LLC, Export, PA on 5/1/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
1242
DISTRIBUTION
Nationwide.
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