China NMPA Product Recall - Single Photon Emission Tomography (SPECT)

On January 24, 2019, GE Medical Systems Israel, Functional Imaging, the manufacturer of SPECT (Single-Photon Emission Tomography) devices, initiated a voluntary Class II recall for its Discovery NM 530c model. This action, reported to the National Medical Products Administration (NMPA) of China and publicly announced on February 18, 2019, stemmed from the discovery that certain units were not equipped with the latest software. This software discrepancy could potentially affect the device's intended function, which is to perform nuclear medicine imaging for clinical diagnosis, particularly in cardiac examinations. The regulatory framework overseeing this recall is the NMPA. Despite the identified software issue, a significant detail is that none of the affected product batches were sold or distributed within the Chinese market. Therefore, the required actions specific to China were primarily administrative, involving the formal reporting of the incident to the NMPA by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., the agent. While no direct customer actions were needed in China, GE Healthcare committed to implementing corrective actions globally to update the software on all impacted SPECT systems, ensuring all devices meet current specifications and operational safety standards.