China NMPA Product Recall - Stereo orientation system

The National Medical Products Administration (NMPA) announced on April 21, 2020, a voluntary Class II recall by Elekta Instrument AB concerning its stereotactic system (Registration Certificate No.: 20193010531). The recall was initiated following a report from Elekta (Shanghai) Medical Device Co., Ltd., which identified a critical defect: the product's support frame did not meet standard specifications. This non-conformance resulted in improper device functionality and posed a potential risk of clinical harm to patients. Elekta Instrument AB is proactively recalling the affected systems to address this issue and ensure patient safety. Detailed information regarding specific models, specifications, and batch numbers is provided in the "Medical Device Recall List" and an accompanying "Medical Device Recall Event Report Form." The document does not specify any inspection dates, focusing on the company-initiated recall under NMPA's regulatory framework.