China NMPA Product Recall - Digital X-ray machine

Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Level III recall for its Digital X-ray Machines, as reported by the National Medical Products Administration (NMPA) on January 28, 2021. This action followed internal testing which revealed an error in the last digit of the medical device registration certificate number displayed on the Chinese equipment label. The company emphasized that this labeling inaccuracy does not compromise the safety or performance of the affected devices, and users can continue to operate the equipment normally. The recall specifically involves two units, identified by serial numbers SN200022 and SN200034. To address the discrepancy, Philips Medical (Suzhou) Co., Ltd. is actively notifying all affected customers. Engineers will be dispatched to customer sites to perform on-site updates, ensuring that the correct medical device registration certificate number is affixed to the product installation for all users, thereby maintaining accurate product information.