China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall for 133 units of its MX 16-slice X-ray Computed Tomography Equipment in China, as reported to the National Medical Products Administration (NMPA) on July 9, 2021. The recall stemmed from customer complaints revealing that product model information on the English and Chinese control console labels did not match the technical requirements previously submitted to the NMPA. The correct product model code is "454110120061". Philips clarified that this labeling discrepancy is administrative and does not impact device safety or functionality, advising users can continue normal operation. As a corrective action, Philips field engineers are contacting affected customers to replace the console labels with the accurate product model information, ensuring compliance with NMPA standards.