China NMPA Product Recall - Single-photon emission and X-ray computed tomography (SPECT) system, single-photon emission computed tomography (SPECT) scanning system

The National Medical Products Administration (NMPA) has announced a Class I voluntary recall initiated by Philips Medical Systems (Cleveland), Inc., with a publication date of December 25, 2023. This recall affects the company's Single-Photon Emission Tomography (SPECT) Systems and Single-Photon Emission Computed Tomography (SPCT) Systems. The core issue, as reported by Philips (China) Investment Co., Ltd., is a critical component failure that could lead to the accidental falling of the detectors within the affected medical devices. This safety concern necessitated a Class I recall, signifying a high probability of serious adverse health consequences or death if the product is used. The regulatory framework highlights the NMPA's oversight in ensuring medical device safety. As a required action, Philips Medical Systems (Cleveland), Inc. is voluntarily recalling these systems to mitigate potential risks. Specific details concerning affected models, specifications, and batches are contained within the "Medical Device Recall Event Report Form," indicating a structured approach to addressing the product deficiency and safeguarding patient well-being.