A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Reason for recall: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system. Distribution: US Nationwide distribution in the state of NY. Quantity: 44 systems Lot/code info: All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.