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

Philips (China) Investment Co., Ltd. initiated a Class II voluntary recall of its Single-Photon Emission Computed Tomography (SPECT) Systems and Single-Photon Emission and X-ray Computed Tomography Imaging Systems, including BrightView and BrightView XCT models. This recall, reported by the National Medical Products Administration (NMPA) on March 17, 2017, addresses several functional issues with the medical devices. Key problems identified include a motion controller issue that may cause the system to stop during XCT scans, a door lock malfunction preventing X-ray scans if the examination room door is not properly closed, and a potential for the detector to contact the headrest during patient unloading. Additionally, the JETStream component may jam during gated plane scanning for patients with arrhythmias. Philips has reported no associated injuries or deaths related to these issues. Under the NMPA’s regulatory framework, Philips has implemented corrective actions, including notifying affected users and issuing Field Corrective Actions (FCOs). Philips (China) engineers are contacting customers to perform necessary system updates and resolve the identified technical deficiencies.