China NMPA Product Recall - Nuclear medicine system

The National Medical Products Administration (NMPA) announced on February 27, 2023, that GE Medical Systems Israel, Functional Imaging, is conducting a voluntary recall and modification of certain nuclear medicine systems. This action, reported by GE Medical Systems Trade Development (Shanghai) Co., Ltd., addresses a critical safety issue involving the fallout of detectors in specific models and batches of its single-photon emission computed tomography (SPECT) and X-ray computed tomography (XCT) imaging systems. Initially released on December 29, 2022, as a Level II recall, the NMPA has elevated the urgency to a Level I recall due to the severity of the potential risk. Furthermore, the scope of affected products has been expanded, necessitating broader corrective measures. This significant change underscores the potential for serious health consequences or death associated with the malfunctioning devices. As part of the NMPA-mandated actions, GE Medical Systems Israel is required to recall all identified affected products and implement additional corrective actions to address the root cause of the detector fallout. Detailed information regarding the specific product models, specifications, and batch numbers subject to this recall is available in the "Medical Device Recall Event Report Form," which serves as the official documentation outlining the comprehensive actions required to resolve this safety concern.