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

On September 8, 2020, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Single-Photon Emission Tomography (SPECT) devices and SPECT/X-ray Computed Tomography Imaging Systems. This action was reported via the Shanghai Municipal Drug Administration Website and falls under the oversight of the National Medical Products Administration (NMPA) regulatory framework. The recall addresses a potential issue where a rotor bearing screw on a detector within the product system could loosen. While this loosening might affect one of the four rotor bearings, the company emphasized that the detector's design incorporates multiple redundancy mechanisms, significantly minimizing the risk of instability. Despite the low probability of malfunction, GE Healthcare proactively decided to recall the affected devices to ensure patient safety and product reliability. Specific devices impacted by this recall include those with Registration Certificate Nos. 20163334732 and 20143335340. The company has provided a "Medical Device Recall Event Report Form" for detailed information regarding affected product models, specifications, and batches, outlining the required actions for customers and distributors to facilitate the recall process. This voluntary recall demonstrates the company's commitment to maintaining high safety standards for its medical equipment.