China NMPA Product Recall - Intracranial pressure probe

Sophisa (France), in cooperation with its local distributor Beijing Meike Innovation Technology Co., Ltd., has initiated a voluntary Class I recall for its intracranial pressure probe. Announced by the National Medical Products Administration (NMPA) on May 8, 2024, the recall is due to critical manufacturing deviations. The specific issue involves irregularities in the process of embedding the probe into the catheter. This defect could potentially compromise the device's performance and patient safety, necessitating the highest level of recall classification. The affected medical device holds National Medical Device Registration Certificate No. 20153072680. Although no specific inspection dates were provided, the voluntary recall demonstrates the manufacturer's proactive approach to addressing a significant quality control concern. The regulatory framework requires Sophisa (France) to retrieve all impacted product batches, with detailed information on affected models, specifications, and batch numbers available in the official "Medical Device Recall Event Report Form." This action highlights the NMPA's stringent oversight to maintain medical device safety and efficacy within the market, with a Class I recall indicating a reasonable probability of serious adverse health consequences or death from product use.