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

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/4ce0ad61-1cbf-4df4-a898-46e186c44a61/
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray Equipment; Mobile C-arm X-ray Machine by Siemens Healthineers Co., Ltd. published April 28, 2020. Recall level: Level 2 Recall. Siemens Healthineers Ltd. has initiated a voluntary Class II recall for specific Mobile C-arm X-ray 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its Mobile C-arm X-ray Equipment.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2020-04-28
- Product Name: Mobile C-arm X-ray Equipment; Mobile C-arm X-ray Machine
- Recall Level: Level 2 Recall
- Recall Reason: A very small number of Cios Spin and Cios Alpha systems equipped with a certain batch of Polydoros M25 (version 04) X-ray generators may have the following issue: When the main cable is disconnected from the X10 connector, an unsafe voltage (maximum 67.6 V DC) may form on the X10 connector. There is a very small chance that the contact pin inside the X10 connector may be touched by the user or someone else, potentially causing electric shock or other problems.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/