China NMPA Product Recall - Ultrasound diagnostic system

On February 13, 2019, Siemens Healthineers announced a voluntary Class II recall of certain ultrasonic diagnostic systems, an action overseen by the National Medical Products Administration (NMPA) and related to certifications from the Shanghai Food and Drug Administration. The recall stems from significant safety concerns where the devices' probes could potentially exceed the specified orbital 3 values and exhibit excessive acoustic output power (AOP) during pulse wave Doppler imaging under particular operating conditions. Exceeding these thresholds indicates that the ultrasound energy emitted might be higher than safe limits, posing potential risks to patients undergoing diagnostic procedures. The affected products include ultrasonic diagnostic systems with registration certificate numbers 20172230583 and 20182230177. A detailed list of impacted models, specifications, and batches is provided in the accompanying Medical Device Recall Event Report Form. This voluntary recall demonstrates Siemens Healthineers' commitment to patient safety and compliance with the stringent medical device regulations established by Chinese authorities, proactively addressing the identified performance anomalies in their diagnostic equipment to mitigate potential hazards.