China NMPA Product Recall - X-ray computed tomography equipment, X-ray computed tomography equipment

Philips (China) Investment Co., Ltd., along with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) equipment. This recall, reported on November 28, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016, addresses a critical performance issue. The affected products include Ingenuity CT and Brilliance 64 models utilizing software versions 4.1.6.XX030 or 4.1.6.XX032. A total of 68 units sold in China are impacted as part of a global recall effort. The primary problem arises during non-gated contrast agent tracking clinical scans, where the equipment malfunctions upon reaching a threshold. This malfunction results in the cancellation of the scan sequence and subsequent loss of contrast agent, requiring potential rescans. Although no adverse events have been reported, Philips has taken decisive action. The company is actively notifying all affected users and implementing Field Corrective Actions through on-site software updates to resolve the issue and ensure product reliability under the NMPA's regulatory oversight.