China NMPA Product Recall - Mobile C-arm X-ray Equipment; Mobile C-arm X-ray Machine

Siemens Healthineers Ltd. has initiated a voluntary Class II recall for specific Mobile C-arm X-ray Equipment, including Cios Spin and Cios Alpha systems, under the regulatory guidance of the National Medical Products Administration (NMPA). This recall, reported on April 28, 2020, and published on August 4, 2020, addresses a critical safety concern. The issue stems from certain batches of Polydoros M25 (version 04) X-ray generators, where an unsafe voltage, reaching up to 67.6 V DC, may be generated on the X10 connector when the main cable is disconnected. This condition poses a slight risk of electric shock if the internal contact pin is touched by users or other personnel. Siemens Healthineers is recalling affected devices, specifically those under Registration Certificate Nos. 20193060388 and 20183302134. Comprehensive details regarding the affected product models and batches are available in the accompanying Medical Device Recall Event Report Form. This action aims to ensure the safety and compliance of the medical devices.