# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/f35702cb-e44d-485f-9feb-c774371082d8/
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips (China) Investment Co., Ltd. published August 04, 2021. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its medical magnetic 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling medical magnetic resonance imaging (MRI) systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-08-04
- Product Name: Medical magnetic resonance imaging system
- Recall Level: Level 3 Recall
- Recall Reason: The pressure reducing valve in the magnet assembly was installed incorrectly; a 3.75 psi pressure reducing valve should have been installed, but a 42 psi pressure reducing valve was actually installed.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its medical magnetic resonance imaging (MRI) systems, as reported on August 4, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by an identified manufacturing error in the magnet assembly of affected products. Specifically, a 42 psi pressure reducing valve was incorrectly installed instead of the required 3.75 psi valve. This discrepancy means that while a 3.75 psi valve would release helium pressure as expected, the incorrectly installed 42 psi valve would not activate until helium pressure reached a significantly higher level. Although all affected devices include a secondary 5 psi pressure reducing valve to mitigate high-pressure helium release, ensuring appropriate amounts of helium are still released, the primary issue necessitated the recall. The affected MRI systems are identified by multiple registration certificate numbers. As of July 2021, the company had not received any user complaints directly related to this specific issue. Philips (China) is undertaking this action under the regulatory oversight of the NMPA, with detailed product information available in the "Medical Device Recall Event Report Form".

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/