ForeSight™ Oximeter Cable

Companies: Edwards Lifesciences LLC, 1 Edwards Way, Irvine, California, United States, 92614.

This recall is regarding inaccurate StO2 readings from the HEMFSM10 ForeSight™ Oximeter Cable due to mispositioning of the sensor cables. Edwards has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device. There is potential that the labels on the green cables may have been switched, with the channel 1 cable labeled as channel 2, and the channel 2 cable labeled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables. Should this potential issue occur during use, the values displayed on the monitor will be switched and will represent the opposite region being monitored. Therefore, there is a potential for incorrect diagnosis, leading to potential delay of appropriate treatment. If either of the labels are missing, or the flag label and/or the sensor label do not match the channel label on the housing, contact the Technical Support. If the flag and sensor labels correctly correspond to the channel labels, there is no further action required.