China NMPA Product Recall - Angiography X-ray system

Shimadzu Enterprise Management (China) Co., Ltd. has initiated a voluntary Class III recall for its angiography X-ray systems, as reported by the Shanghai Municipal Drug Administration and published by the National Medical Products Administration (NMPA) on December 6, 2021. The recall addresses a critical safety concern where, under specific conditions, the irradiation dose rate may exceed manufacturer-specified limits. This potential issue stems from a very small probability that if the maximum dose rate is not strictly verified during equipment installation and commissioning, it could lead to excessive radiation exposure during non-standard procedures. The company's proactive measure ensures compliance with regulatory standards and prioritizes patient safety. While no specific inspection dates are detailed in this document, the recall action itself highlights the company's commitment to addressing product performance deviations. The required action is a comprehensive Class III recall of affected angiography X-ray systems, with specific models and batches detailed in an accompanying Medical Device Recall Event Report Form. This recall falls under the regulatory oversight of the NMPA, underscoring the importance of adherence to established operational and safety protocols for medical devices.