China NMPA Product Recall - Single-photon emission computed tomography system

Philips Medical Systems (Cleveland), Inc., through its Chinese affiliate Philips (China) Investment Co., Ltd., initiated a voluntary recall of its Single-Photon Emission Computed Tomography (SPECT) Systems, specifically BrightView X and BrightView XCT models. This recall was reported by the Shanghai Food and Drug Administration on January 14, 2014, and publicly noted by the National Medical Products Administration (NMPA) on January 28, 2014, stemming from Philips' internal report dated December 24, 2013. The regulatory framework for this recall is established under NMPA Index No. JGXX-2014-10009. The main violations concern critical software issues affecting 38 units imported into China. These issues include incorrect calculation of patient rotation trajectories during non-circular acquisitions, leading to potential detector-patient contact. Additionally, there are concerns about detectors making contact with patients or operators during gantry movement to a 90-degree scanning position if hands or arms are in the path. A third issue, specific to BrightView X/XCT, involves the bed board support bracket being misaligned, potentially causing pressure points or bed tilt. These deficiencies pose a risk of serious injury. The required actions involve Philips Healthcare issuing a field safety notice and a corrective action field change order (FCO). Field service engineers will implement on-site software updates to rectify these issues, with provincial and municipal food and drug administrations overseeing compliance.