China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. is voluntarily recalling its X-ray Computed Tomography Equipment (CFDA Medical Device Approval Nos. 3300671, 20143300672) due to image artifacts, as reported to the National Medical Products Administration (NMPA) on May 19, 2016, with the recall published on July 8, 2016. This Class III recall affects models like Ingenuity Flex and Brilliance CT 16. The primary issues are software-related. First, tracking image artifacts may appear in CT angiography (CTA) scans, potentially causing incorrect scan triggering and generating suboptimal images unsuitable for diagnosis. Second, intermittent ring/dot image artifacts can occur in reconstructed images after a complete system power-off and power-on, particularly if a head scan is performed without air correction or a fast IQ check. No injuries have been reported in relation to these issues. Philips Healthcare (Suzhou) Co., Ltd. will issue a Field Correction Order (FCO) to affected customers across regions including Canada, Mexico, Germany, Singapore, and Japan. Field service engineers will contact customers to arrange the necessary software upgrades to resolve these identified deficiencies. Six units were sold and manufactured in China.