China NMPA Product Recall - Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc. initiated a voluntary recall for specific models and batches of its Diagnostic Ultrasound System, as reported on July 23, 2021. This action is overseen by the National Medical Products Administration (NMPA). The primary issue identified is that certain affected systems, when equipped with particular battery packs, may fail to power on properly when not connected to an external power source. This operational flaw could impact the system's availability and functionality in situations where external power is critical or unavailable. The recall has been classified as Level II, signifying a situation where the potential for adverse health consequences is temporary or medically reversible, or the probability of serious harm is remote. As a required action, Siemens Medical Solutions USA, Inc. is actively recalling the affected products. Comprehensive information regarding the precise models, specifications, and batch numbers of the impacted devices is detailed in the accompanying "Medical Device Recall Event Report Form" to facilitate proper identification and management by users and distributors.