China NMPA Product Recall - Fully digital color ultrasound monitoring hysteroscopic surgery instrument

Wuxi Belson Imaging Technology Co., Ltd. has initiated a voluntary Class III recall of its all-digital color ultrasound monitoring hysteroscopic surgery instrument. This action stems from findings during a random inspection conducted by the National Medical Products Administration (NMPA), with the recall publicized on August 10, 2022. The regulatory body identified two critical performance deviations in the device: insufficient detection depth in Doppler mode at an 8MHz frequency and excessive blood flow difference, also in Doppler mode. These issues suggest the instrument may not reliably perform its intended diagnostic functions, posing potential concerns for patient safety and diagnostic accuracy. Operating under the regulatory framework of the NMPA, the company is taking proactive steps to remove all affected units from distribution and use, as detailed in the 'Medical Device Recall Event Report Form'. This recall underscores the NMPA's commitment to ensuring the quality and safety of medical devices through rigorous oversight and mandatory compliance measures, prompting manufacturers to address product deficiencies promptly and responsibly.