China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for 60 units of its Ingenuity Core 128 X-ray computed tomography equipment in China, formally reported to the National Medical Products Administration (NMPA) on November 3, 2017. This action addresses ten identified software vulnerabilities within version 4.1.6 of the device. These issues can affect diagnostic workflows and equipment performance.

Prominent problems include inconsistent ECG signal detection during cardiac scans, potential for scans to commence outside the intended range, and respiratory wave signals appearing during cardiac workflows following lung-gated scans. Other significant concerns involve unintended changes to total acquisition length when modifying scan plans, and instances where thin-slice images may not appear in patient catalogs or lead to reconstruction application failures. Operators may also encounter application failures during 3D calcium scoring scans, receive "tube overheating" messages, or experience scan abortions due to memory overflow. Critical system issues include a lack of error notifications upon disconnection from the Reconstruction System and RHost code problems that can alter generator configuration.

This medical device operates under the regulatory framework of CFDA Medical Device Approval No. 20133301488. Philips Healthcare (Suzhou) Co., Ltd. will resolve these issues by notifying affected customers and implementing on-site corrective actions through a comprehensive software update. No patient injuries or fatalities have been associated with these software anomalies.