China NMPA Product Recall - Medical angiography X-ray system

On March 13, 2020, Philips Medical Systems Nederland B.V., facilitated by Philips (China) Investment Co., Ltd., initiated a voluntary Class II recall of specific medical angiography X-ray systems under the oversight of the National Medical Products Administration (NMPA). The primary issue identified was a manufacturing deviation where four critical screws, connecting the C-arm rolling motor's internal gearbox to the fixing flange, were not torqued to the specified standard. This deficiency poses a significant risk of system failure, potentially rendering the X-ray equipment unusable during medical procedures.

This action falls under the NMPA's regulatory framework for medical device safety, emphasizing a company's responsibility to address product defects proactively. The recall level II designation indicates that the product defect may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a required action, Philips Medical Systems Nederland B.V. is systematically retrieving the affected medical angiography X-ray systems, identifiable by Registration Certificate No. 20193060317, to implement necessary corrective measures. Detailed information regarding specific product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form," ensuring transparency and facilitating the effective removal and correction of the non-conforming devices from the market to maintain patient safety and product reliability.