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., in collaboration with manufacturer Philips Medical Systems (Cleveland), Inc., has initiated a voluntary Level III recall of its Single-Photon Emission Tomography (SPECT) systems and Single-Photon Emission and X-ray Computed Tomography (SPECT) imaging systems. This action, reported to the National Medical Products Administration (NMPA), addresses a potential safety concern identified during specific operational modes.The primary issue involves the imaging probes of the affected systems potentially making contact with a patient's body during a "non-circular, non-automatic human body tracking dual-probe 180-degree relative scan." While a touch sensor is designed to pause the scan upon contact, thus mitigating immediate harm, Philips proactively decided to recall the products to prevent potential patient interaction with the equipment. Importantly, no injuries or fatalities related to this issue have been reported.As part of its corrective actions, Philips has informed all affected users and issued a Field Corrective Action (FCO). Trained Philips field engineers will directly contact customers to implement necessary system updates, ensuring the resolution of the identified issue across the 19 affected units imported into China and globally. This voluntary recall underscores the company's commitment to patient safety and adherence to regulatory standards under the NMPA framework.