# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/ccf63968-93b9-4f96-94ee-a61682341520/
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips Medical Systems published September 05, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on September 5, 2024, a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems Nederland B.V. is voluntarily recalling its medical magnetic resonance imaging (MRI) systems.
- Company Name: Philips Medical Systems
- Publication Date: 2024-09-05
- Product Name: Medical magnetic resonance imaging system
- Recall Level: Level 3 Recall
- Recall Reason: A few products may lack a safety shield on the conductor of the gradient coil.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: The National Medical Products Administration (NMPA) announced on September 5, 2024, a voluntary Class III recall initiated by Philips Medical Systems Nederland B.V., reported by Philips (China) Investment Co., Ltd. This recall pertains to certain medical magnetic resonance imaging (MRI) systems due to a potential safety concern. The primary issue identified is a possible lack of safety shielding on the conductors of the gradient coil in a small number of affected products. This deficiency could pose a risk to patient or operator safety. Operating under the NMPA's regulatory framework, Philips is undertaking this recall to address the identified product issue. The specific MRI systems involved are those registered under NMPA Import Medical Device Registration Nos. 20083281795 and 20133284026. It is noted that the products subject to this recall were not imported, suggesting they are units distributed domestically within China. Further detailed information regarding specific models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form." This voluntary action demonstrates the company's commitment to product safety and compliance with NMPA regulations.

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