Devices

Device Recall SmartMonitor 2 PS/PSL

Model / Serial
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.
Product Classification
Neurological Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution.
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.
Manufacturer
Circadiance LLC
1 Event
- Recall of Device Recall SmartMonitor 2 PS/PSL

Manufacturer

Circadiance LLC

Manufacturer Address
Circadiance LLC, 1060 Corporate Ln, Export PA 15632-8905
Manufacturer Parent Company (2017)
Circadiance LLC
Source
USFDA

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