Class I - Dangerous
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.