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

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/32a8b704-50dd-4cdc-b98d-34f77b329e8b/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Siemens Healthineers Co., Ltd. published September 30, 2021. Recall level: Level 2 Recall. Siemens Healthineers initiated a voluntary Class II recall for its Artis Zeego medical angiography X

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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: 2021-09-30
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: A potential issue with a very small percentage of Artis zeego systems is that if the examination table rotates more than 4° in any direction, the software may misinterpret the rotation. This could result in the 3D image reconstruction showing a rotation of up to 5° relative to the patient, leading to inappropriate use by the system.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: Siemens Healthineers initiated a voluntary Class II recall for its Artis Zeego medical angiography X-ray machines, as reported by the National Medical Products Administration (NMPA) on September 30, 2021. This action addresses a software anomaly discovered during the manufacturer's system testing. The core issue involves the Artis Zeego system's software misinterpreting examination table rotations exceeding 4 degrees. This misinterpretation can cause the 3D image reconstruction display to be rotated by up to 5 degrees relative to the patient, potentially leading to improper system usage. While identified during internal testing, Siemens Healthineers stated that no installed Artis Zeego systems had exhibited this problem at the time of the recall report. The recall, overseen by the NMPA's regulatory framework, mandates the company to address this software defect. Detailed information regarding affected product models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form." This proactive recall highlights Siemens Healthineers' commitment to patient safety and product integrity, ensuring that medical devices function accurately in clinical environments.

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