Safety Notice for ACUSON X300, ACUSON and SONOLINE Antares, ACUSON S2000, Siemens Medical Solutions
2010.10.21
Product group Ultrasonics
Reference 03389/10
Siemens Medical Solutions has issued a Field Safety Notice about an error in the Cardiac measurement package provided on ACUSON X300, ACUSON and SONOLINE Antares, ACUSON S2000 ultrasound systems.
The implemented calculation will result in an underestimation of the mean pressure gradient across a stenotic valve when estimated from a trace of the Doppler waveform of the stenotic flow.
The potential risk is underestimation of the severity of a stenosis.