China NMPA Product Recall - Forte Gamma Camera System

Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of its Forte Gamma Camera System on October 16, 2019, as publicly reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by a discovered issue where detector 1 or detector 2 of the gamma camera system could inadvertently slide vertically to the limit of its travel range without obstruction. While no serious injuries or deaths worldwide have been attributed to this potential problem, the company is taking proactive steps to address the safety concern. The affected devices fall under Registration Certificate No.: CFDA (Imported) 2005 No. 3313349 (Revised). This action demonstrates adherence to the regulatory framework overseen by the NMPA, ensuring medical device safety and quality. Detailed information regarding the specific models, specifications, and batches of the affected products is provided in the associated "Medical Device Recall Event Report Form," requiring the company to implement appropriate actions to remove or correct the devices.