China NMPA Product Recall - Breast X-ray biopsy localization system

Hologic, Inc., the manufacturer, is voluntarily recalling its Breast X-ray Biopsy Localization System due to a significant safety concern: excessive radiation leakage. This recall was reported by Beijing Hologic Technology Co., Ltd. and is being overseen by the National Medical Products Administration (NMPA) under recall index JGXX-2024-10092, with the announcement made on June 14, 2024. The affected product, identified by National Medical Device Registration Certificate No. 20223060310, is subject to a Class III recall. A Class III recall indicates a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences. Specific details regarding the models, specifications, and batch numbers involved are available in the attached "Medical Device Recall Event Report Form". This action underscores the company's responsibility to address product safety issues and comply with regulatory standards set forth by the NMPA, ensuring patient safety in medical device usage.