Field Safety Notice: Gynesonics - Sonata Radiofrequency Ablation Handpiece

donderdag 5 januari 2017 18:00

Gynesonics has determined that ingress of blood or blood mixed with non-conductive ultrasound coupling fluid into the handle of the RFA Handpiece can lead to malfunction of the electronics that control display of the Ablation Guide, potentially leading to a discrepancy between the displayed ablation size and the ablation size that would result from actual needle electrode deployment.