Recall for VolumeView Set Thermodilution Cable Model EVVVTC1-Accessory to the EV1000 Clinical Platform, Edwards Lifesciences
2011.11.29
Product group Medical electronics / Electromedical devices
Reference 05403/11
Edwards Lifesciences has issued a Field Safety Notice of potential safety issues associated with the VolumeView Set Thermodilution Cable with several Serial Numbers.
Blood temperature baseline can be affected by the oscillation of main line frequency in a certain range.