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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/97151464-f7ac-468a-8284-a1fe7ad6f99f/
Source feed: China

> China NMPA product recall for Medical angiography X-ray system by Philips Medical Systems published January 20, 2020. Recall level: Level 3 Recall. Philips Medical Systems Nederland B.V. initiated a voluntary Class III recall of its medical angiogr

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems Nederland B.V. is voluntarily recalling its medical angiography X-ray systems.
- Company Name: Philips Medical Systems
- Publication Date: 2020-01-20
- Product Name: Medical angiography X-ray system
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves a product software bug that causes unsubtracted DSA images to be displayed when exported to the application.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems Nederland B.V. initiated a voluntary Class III recall of its medical angiography X-ray systems, as reported by Philips (China) Investment Co., Ltd. to the National Medical Products Administration (NMPA) on January 20, 2020. This recall addresses a critical software error where unsubtracted Digital Subtraction Angiography (DSA) images were inadvertently displayed when exported to an application. This issue could potentially compromise the diagnostic accuracy of the medical devices, which are vital for visualizing blood vessels and detecting abnormalities. The affected products include specific models registered under certificate numbers 20193060314, 20193060315, 20193060317, and 20193060319. While the detailed specifications and batch information are contained within an accompanying 'Medical Device Recall Event Report Form,' the Class III classification indicates that the issue, while serious, is unlikely to cause severe adverse health consequences. This action aligns with the NMPA's regulatory oversight to ensure the safety and efficacy of medical devices within China. The recall underscores the manufacturer's responsibility to correct software anomalies that could impact clinical utility and patient care.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/