China NMPA Product Recall - Medical angiography X-ray system, medical vascular landscaping

The National Medical Products Administration (NMPA) announced on May 22, 2023, a voluntary Class III recall initiated by Philips Medical Systems Nederland B.V. This action addresses critical safety and functionality concerns impacting their medical angiography systems. One primary issue identified involves a potential problem within the high-voltage generator assembly of specific medical angiography X-ray systems. This defect prevents the equipment from generating X-rays, rendering it unable to perform diagnostic functions normally. Separately, Philips Medical Systems Nederland B.V. is also recalling other medical angiography devices due to a potential electric shock risk, posing a significant safety hazard to both users and patients. Philips (China) Investment Co., Ltd. reported these findings to the NMPA. The recall encompasses medical angiography X-ray systems with specific registration certificates, such as 20193060317 and 20223060257, and other angiography devices, including those under certificate 20143065290. The Class III classification indicates that while adverse health consequences are unlikely, corrective measures are essential to uphold product safety and operational integrity. Comprehensive details on affected models and batches are available in the official "Medical Device Recall Event Report Form."