# China NMPA Product Recall - Medical angiography X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/b51ec17a-9714-4e5f-9c98-952eb8b38bdc/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Siemens Healthineers Co., Ltd. published June 03, 2021. Recall level: Level 2 Recall. On June 3, 2021, the National Medical Products Administration (NMPA) announced a voluntary Level II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its medical angiography X-ray machines.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2021-06-03
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: If the drive system of a certain axis malfunctions and is not repaired in time, the C-arm may deviate from its expected travel path during step imaging, with a small probability.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On June 3, 2021, the National Medical Products Administration (NMPA) announced a voluntary Level II recall initiated by Siemens Healthineers for its medical angiography X-ray machines. The recall stems from a potential safety issue identified during factory system testing: a malfunction in a drive system on one axis could cause the C-arm to deviate from its intended path during step-by-step imaging if not promptly repaired. While this issue was discovered internally, Siemens Healthineers reported that it had not occurred in any existing user systems at the time of the recall announcement. The regulatory action falls under the NMPA's oversight, with Siemens Healthineers proactively addressing the identified risk. The company is undertaking a voluntary recall of affected angiography X-ray machine models, which are identified by Registration Certificate No.: 国械注进20183300137. Specific details regarding the affected products, including models, specifications, and batch numbers, are provided in the "Medical Device Recall Event Report Form" attached to the official notice. This action underscores the company's commitment to product safety and compliance with medical device regulations, ensuring potential risks are mitigated even before reaching patient use environments. The recall aims to prevent any future incidents related to the C-arm's precise movement.

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