Reported Jun 14, 2017 · Terminated
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration,…
Circadiance LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Circadiance LLC · 1060 Corporate Ln · Export, PA · 15632-8905
Is this the product you have?
- 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.
- Lot codes and dates
- Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140. All serial numbers of units with "REF", "MODEL" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice. Monitors with the above part numbers that have a serial number starting with "CP" are NOT affected by this issue.
- Amount recalled
- 1,242 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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