China NMPA Product Recall - X-ray computed tomography equipment

Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall of its X-ray Computed Tomography Equipment, as announced by the National Medical Products Administration (NMPA) on August 11, 2017. The recall addresses critical software problems identified in the affected devices. These issues could potentially result in unexpected patient radiation exposure and the production of unclear images, impacting both patient safety and diagnostic accuracy. This action falls under the regulatory oversight of the NMPA, which governs medical device registration and import in China, as indicated by the referenced National Medical Device Registration Certificate and Import Certificate. While specific inspection dates were not detailed, the company's decision to conduct a voluntary recall underscores its commitment to product safety and regulatory compliance. Philips is taking required actions to address these deficiencies, and further specifics regarding affected product models, specifications, and batches are available in an associated recall event report form.