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

Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall of its X-ray Computed Tomography (CT) Systems. This action was reported to the National Medical Products Administration (NMPA) on November 27, 2015, addressing three significant software-related deficiencies that could impact diagnostic accuracy and treatment planning. The identified issues include inaccurate image positioning, where incorrect angular offsets might affect radiotherapy planning. Additionally, tracking scan images in CT angiography (CTA) examinations displayed linear artifacts, potentially resulting in suboptimal image quality unsuitable for clinical diagnosis. Lastly, specific head scans performed after a system power cycle were prone to intermittent ring/dot artifacts if air correction or a rapid IQ scan was not utilized. This global recall encompasses 254 units imported into China. No injury incidents have been reported. Philips has proactively issued Field Corrective Actions (FCO 72800635), notifying affected users, and its field engineers are coordinating software upgrades with customers to resolve these issues and ensure the safe and intended performance of the CT systems.