China NMPA Product Recall - Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc. has initiated a voluntary Class II recall for specific models and batches of its ACUSON Sequoia Diagnostic Ultrasound System. Announced by the National Medical Products Administration (NMPA) on December 2, 2021, this action addresses a software anomaly. The issue involves the 2D manual tracing function, where the calculated perimeter value may be overestimated, even though the underlying measurement data is accurate. This discrepancy could potentially lead to misinterpretation of diagnostic results if clinicians rely solely on the inflated perimeter value. Siemens Medical Solutions USA, Inc. is proactively recalling the affected units to mitigate any risk of inaccurate clinical assessments and ensure product reliability. Further details on the specific models and batches involved are available in the associated "Medical Device Recall Event Report Form." This voluntary recall highlights the manufacturer's commitment to promptly resolving product performance concerns under regulatory oversight.