China NMPA Product Recall - X-ray computed tomography (CT) system

The National Medical Products Administration (NMPA) published a Level III voluntary recall notice on July 6, 2016, initiated by Philips (China) Investment Co., Ltd. The recall addresses a critical software issue found in Philips' Brilliance and Ingenuity series X-ray Computed Tomography (CT) systems, manufactured by Philips Medical Systems (Cleveland), Inc.

The primary concern is a software malfunction that can lead to unexpected radiation exposure and incomplete image data. This flaw may necessitate patient rescanning or introduce difficulties in diagnostic interpretation. Affected models encompass Brilliance ICT, Brilliance ICT SP, Ingenuity CTO, and Brilliance 64 CT. In China, 212 units were imported, with 199 having been sold to facilities.

In response, Philips, reporting internally on May 12, 2016, has informed all affected users and implemented a Field Corrective Action (PCO). This action involves deploying field engineers to contact customers and perform necessary software upgrades to resolve the identified safety and performance issues. Currently, no patient injuries have been reported in connection with this software defect.