China NMPA Product Recall - Single-photon emission computed tomography (SPECT) system; single-photon emission computed tomography and X-ray computed tomography imaging system; single-photon emission computed tomography and X-ray computed tomography imaging system

The National Medical Products Administration (NMPA) announced on December 31, 2020, that GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is undertaking a voluntary Level II recall of various single-photon emission computed tomography (SPECT) devices and combined SPECT/CT systems. This action by GE Healthcare covers multiple product models, including those with registration certificate numbers such as 20163334732, 20173337255, and 20143335340. While the precise reasons or main violations prompting this recall are not detailed in the public notification, comprehensive information regarding affected product specifications and batches is made available through the "Medical Device Recall Event Report Form." This document is critical for stakeholders to understand the scope and implications of the recall. Under the NMPA's regulatory framework, the company's required action is to facilitate this voluntary recall process, ensuring all necessary details and procedures are followed as outlined in the attached report. This oversight demonstrates the NMPA's commitment to ensuring the safety and quality of medical devices in the market.