China NMPA Product Recall - Stereo orientation system

Elekta Instrument AB (Sweden) Medical Devices Ltd., with the involvement of Elekta (Shanghai) Medical Devices Co., Ltd., has initiated a voluntary Class III recall for its stereotactic system. This action, publicly reported on April 23, 2023, stems from a critical error identified in the version of the instruction manual provided with certain components of the device. The affected stereotactic system is registered under National Medical Device Registration Certificate No. 20142056130.

This recall addresses a concern where inaccurate instructional information could potentially compromise the proper operation or maintenance of the device. While specific inspection dates are not detailed, the recall announcement itself serves as a regulatory measure overseen by the National Medical Products Administration (NMPA). Elekta is taking proactive steps to correct this documentation discrepancy.

Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in an accompanying "Medical Device Recall Event Report Form." This voluntary recall highlights the manufacturer's dedication to upholding regulatory standards and ensuring all product information is precise and current, thus preventing any potential risks linked to incorrect documentation. Customers should consult the official recall report for specific product identification and necessary actions.