# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/d37ce2fa-a7fe-438a-b568-08335143a1ba/
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips Medical Systems published November 28, 2023. Recall level: Level 1 Recall. Philips Medical Systems Nederland B.V., specifically its Business Unit Magnetic Resonance-site Best,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems Nederland B.V. Business Unit Magnetic Resonance-site Best: Proactive Recall of Medical Magnetic Resonance Imaging Systems
- Company Name: Philips Medical Systems
- Publication Date: 2023-11-28
- Product Name: Medical magnetic resonance imaging system
- Recall Level: Level 1 Recall
- Recall Reason: The products in question may experience issues such as unexpected excessive helium pressure during magnet quenching, or structural integrity failure of Panorama HFO system components.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems Nederland B.V., specifically its Business Unit Magnetic Resonance-site Best, has initiated a Level 1 voluntary recall of certain medical magnetic resonance imaging systems. This action, reported by Philips (China) Investment Co., Ltd., was publicly announced by the National Medical Products Administration (NMPA) on November 28, 2023. The recall addresses critical issues identified in the affected devices, including the potential for excessive helium pressure during magnet quenching and a risk of structural integrity failure in components of the Panorama HFO system. These findings necessitate the highest level of recall due to potential safety concerns. Operating under the NMPA's regulatory framework, Philips is required to retrieve and address these product deficiencies. The company has issued a "Medical Device Recall Event Report Form" which provides comprehensive details regarding the specific models, specifications, and batches of the medical devices involved in this recall, ensuring compliance with regulatory standards for product safety.

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