China NMPA Product Recall - Single-photon emission computed tomography (SPECT) system, single-photon emission and X-ray computed tomography imaging system (models: Bright View, 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 (XCT) 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 on April 6, 2017, affects 38 units globally. The primary issues identified include a motion controller malfunction that could cause the system to stop during XCT scans, a door lock device error preventing X-ray scans if the examination room door is not properly closed, and the detector contacting the patient headrest during patient unloading procedures in specific configurations. Additionally, the JETStream component may jam during gated plane scanning, particularly in patients with arrhythmias. Philips emphasized that no related injuries or deaths have been reported for these issues. As part of the recall, Philips has taken responsibility for the affected products manufactured by Philips Medical Systems (Cleveland), Inc. The company has notified all affected users and implemented a Field Corrective Action (FCO) to address and rectify these identified problems, ensuring patient safety and system functionality. This proactive measure aims to resolve the technical defects under the NMPA's regulatory oversight.