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.
FDA Recall Z-2250-2017 · Posted None
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Recalling FirmCircadiance LLC
Recall StatusTerminated
Product CodeNPE
Date Initiated2017-05-01
Date Terminated2018-02-05
Product Quantity1,242 units
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.
Firm Action
Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to [email protected]. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free of charge, or for questions or support.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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