China NMPA Product Recall - Single-photon emission computed tomography (SPECT) system; Single-photon emission and X-ray computed tomography imaging system; BrightView, Brightview X, Brightview XCT

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its Single-Photon Emission Computed Tomography (SPECT) and Single-Photon Emission and X-ray Computed Tomography (SPECT/CT) Imaging Systems, including BrightView, BrightView X, and BrightView XCT models. The recall, reported to the National Medical Products Administration (NMPA) on February 13, 2017, and published March 17, 2017, addresses four critical deficiencies affecting 38 units globally, manufactured by Philips Medical Systems (Cleveland), Inc.

The main issues include a motion controller problem that can cause the system to stop during XCT scans, a door lock device malfunction preventing X-ray scans, the detector potentially contacting the patient headrest during unloading, and JETStream jamming during gated plane scanning for patients with arrhythmias. Importantly, no related injuries or deaths have been reported due to these issues. Under the NMPA's framework, Philips is implementing a Field Corrective Action (FCO) to rectify these problems, and all affected customers have been notified to ensure prompt resolution of these operational concerns with the medical imaging systems.