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

On May 8, 2017, Philips (China) Investment Co., Ltd. initiated a voluntary recall of its Single-Photon Emission Tomography (SPECT) Systems and X-ray Computed Tomography Imaging Systems. This action was taken in response to a critical issue identified within the company's products. Philips discovered a potential defect in the probe braking system of these medical devices. This malfunction could lead to one or both probes exceeding their mechanical operational limits, posing a risk to device functionality and potentially patient safety. The recall was conducted under the oversight of the National Medical Products Administration (NMPA), the regulatory body responsible for medical device safety in China. As part of its commitment to product quality and patient welfare, Philips (China) Investment Co., Ltd. proactively decided to remove the affected systems from the market. The specific models, specifications, and batch numbers of the recalled products are detailed in the "Medical Device Recall Event Report Form," an attachment associated with the NMPA's official announcement. This voluntary recall underscores the company's responsibility in addressing significant product performance issues to ensure compliance with medical device standards.