Recall Z-2250-2017— Circadiance LLC

Name: FDA recall Z-2250-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-01

Class II · Terminated

Class II FDA medical device recall by Circadiance LLC, initiated 2017-05-01, terminated 2018-02-05. It names one FDA 510(k) clearance: K061256. 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.. 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: Circadiance LLC
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Terminated: 2018-02-05
Firm location: Export, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K061256 — SMARTMONITOR 2PSRespironics, Inc.·cleared 2006-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.