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. has initiated a voluntary Class II recall for its Single-Photon Emission Computed Tomography (SPECT) systems and Single-Photon Emission and X-ray Computed Tomography imaging systems. This action, publicly reported by the National Medical Products Administration (NMPA) on March 17, 2017, addresses significant operational and safety concerns identified within these medical devices. The company discovered several critical deficiencies, including instances where the motion controller issues warning messages that could lead to unexpected system stoppages. Furthermore, malfunctions in the door lock device during X-ray scanning have been observed, alongside a problem where the detector may contact the headrest. An additional issue involves JETSream jamming during door-controlled plane scanning, potentially compromising diagnostic procedures. Operating under the oversight of the NMPA, the regulatory authority responsible for medical products in China, Philips (China) proactively decided to recall the affected products. A Class II recall indicates that while the identified problems could cause temporary or reversible adverse health consequences, the probability of serious harm is remote. The company is undertaking the necessary actions to retrieve all implicated systems. Specific details regarding the models, specifications, and batches of the recalled products are comprehensively documented in the "Medical Device Recall Event Report Form" attached to the official NMPA notification. This recall underscores a commitment to addressing product performance issues and maintaining patient safety standards in line with national medical device regulations.