China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. voluntarily initiated a Level III recall of its X-ray computed tomography equipment (CFDA Medical Device Approval No. 20133301488) on November 6, 2017, due to a significant software vulnerability. This recall, reported to the National Medical Products Administration (NMPA) on November 3, 2017, affects 60 units of Ingenuity Core 128 models in China. The core issue lies with software version 4.1.6, which exhibited ten critical defects. These include instances where the ECG signal was not detected during cardiac workflows, scans initiated outside the intended range, and unexpected respiratory signals after lung-gated scans. Other serious problems involved changes in acquisition length when modifying scan plans, missing thin-slice images in patient catalogs leading to reconstruction failures, and application crashes during 3D calcium scoring setup. Furthermore, the equipment suffered from tube overheating warnings, memory overflow issues aborting scans, and a lack of error notifications upon reconstruction system disconnection. A final issue involved generator monitoring problems if the system was quickly restarted. Philips reported no injuries or deaths related to these issues. As a corrective measure, Philips Healthcare (Suzhou) Co., Ltd. committed to informing all affected customers and implementing on-site corrective actions, specifically updating the system software to resolve these identified vulnerabilities.