# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/7f04590c-00ea-448c-a0a8-b4b3fa68ccf8/
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips Medical Systems published June 20, 2024. Recall level: . Philips Medical Systems Nederland B.V. has initiated a voluntary recall of specific medical magnetic

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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: 2024-06-20
- Product Name: Medical magnetic resonance imaging system
- Recall Reason: Because the torso coil may generate localized heat during the scan, potentially causing harm to the patient, etc.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems Nederland B.V. has initiated a voluntary recall of specific medical magnetic resonance imaging systems, as announced by the National Medical Products Administration (NMPA) of China. This recall, reported by Philips (China) Investment Co., Ltd., addresses a critical safety concern involving the potential for localized heating of the torso coil during patient scanning. Such heating poses a risk of harm to patients undergoing these medical imaging procedures. The regulatory oversight for this action is provided by the NMPA, as indicated by the official publication (Index No. JGXX-2024-10103, dated 2024-06-20). This voluntary recall highlights the company's proactive commitment to product safety and compliance within the regulatory framework governing medical devices in China. The document does not specify inspection dates, as this is a manufacturer-initiated recall announcement rather than a report stemming from a regulatory inspection. The required action involves the recall of the affected medical magnetic resonance imaging systems. Detailed information, including the precise models, specifications, and batches of the products implicated in this safety notice, is available in an accompanying "Medical Device Recall Event Report Form." This measure is crucial to mitigate potential risks and ensure the continued safety and efficacy of medical devices used in patient care.

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