China NMPA Product Recall - Portable color ultrasound diagnostic system; Portable color ultrasound diagnostic instrument; Color ultrasound diagnostic equipment

On May 22, 2019, Fujifilm (China) Investment Co., Ltd. initiated a voluntary Level III recall, affecting multiple models of its medical imaging devices in China. The recall, overseen by the National Medical Products Administration (NMPA), specifically targets portable color ultrasound diagnostic systems, portable color ultrasound diagnostic instruments, and color ultrasound diagnostic equipment, which are identified by several distinct registration certificate numbers including 20182060347, 20153233190, and others. While specific inspection dates were not provided in the document, the recall was announced to address a critical labeling issue. The main violation involved the omission of the manufacturer's Chinese name from the product labels and instructions for the identified batches. This oversight required immediate corrective action to ensure product transparency and compliance with local regulatory standards. As a required action, Fujifilm (China) Investment Co., Ltd. must now update the product labels and instructions for the affected devices to accurately include the manufacturer's Chinese name. This voluntary recall underscores the company's commitment to rectify identified discrepancies and maintain adherence to the NMPA's stringent medical device regulations, ensuring patient safety and proper device identification.