# China NMPA Product Recall - Medical angiography X-ray system, medical vascular landscaping

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/37cd5d50-1387-435a-a7d2-012af4625419/
Source feed: China

> China NMPA product recall for Medical angiography X-ray system, medical vascular landscaping by Philips Medical Systems published May 22, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on May 22, 2023, a voluntary Class III

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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: 2023-05-22
- Product Name: Medical angiography X-ray system, medical vascular landscaping
- Recall Level: Level 3 Recall
- Recall Reason: A potential problem exists with the high-voltage generator assembly, causing the equipment to fail to generate X-rays and thus malfunction; there is also a potential risk of electric shock.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: The National Medical Products Administration (NMPA) announced on May 22, 2023, a voluntary Class III recall initiated by Philips Medical Systems Nederland B.V. This action addresses critical safety and functionality concerns impacting their medical angiography systems. One primary issue identified involves a potential problem within the high-voltage generator assembly of specific medical angiography X-ray systems. This defect prevents the equipment from generating X-rays, rendering it unable to perform diagnostic functions normally. Separately, Philips Medical Systems Nederland B.V. is also recalling other medical angiography devices due to a potential electric shock risk, posing a significant safety hazard to both users and patients. Philips (China) Investment Co., Ltd. reported these findings to the NMPA. The recall encompasses medical angiography X-ray systems with specific registration certificates, such as 20193060317 and 20223060257, and other angiography devices, including those under certificate 20143065290. The Class III classification indicates that while adverse health consequences are unlikely, corrective measures are essential to uphold product safety and operational integrity. Comprehensive details on affected models and batches are available in the official "Medical Device Recall Event Report Form."

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