# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/b6f3ec84-0db4-40bd-a0a3-021d278fc30f/
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips Healthcare (Suzhou) Co., Ltd. published July 30, 2021. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Medical Magnetic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. voluntarily recalls medical magnetic resonance imaging systems
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2021-07-30
- Product Name: Medical magnetic resonance imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Philips detected a pressure relief valve issue during the assembly of the MRI magnet. The actual installed pressure relief valve was a 42PSI valve. Only with a 42PSI valve installed would pressure relief occur. A minor rupture occurred in the helium pressure assembly when the cooling system was shut down for more than a day. If the rupture diaphragm ruptures slightly, and the system pressure increases, the helium ventilation ducts may freeze and become blocked. This results in a rapid release of helium, potentially accompanied by the ejection of mechanical parts.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Medical Magnetic Resonance Imaging (MRI) Systems, as reported by the National Medical Products Administration (NMPA) on July 30, 2021. The recall stems from a manufacturing issue where an incorrect 42 PSI pressure relief valve was installed during the assembly of MRI magnets. This defect poses a risk if the cooling system is inactive for more than one day, potentially leading to a slight rupture in the component and an increase in helium pressure. Such an event could cause the helium ventilation duct to freeze and block, resulting in rapid helium release and the possible ejection of mechanical parts, ultimately risking the rupture of the magnet container. The recall affects 63 units globally, encompassing specific models like Prodiva 1.5T CS, Prodiva 1.5T CX, and Multiva 1.5T, identified by their serial numbers. Although no customer complaints related to this issue have been reported, Philips Healthcare (Suzhou) is proactively addressing the safety concern. Under the NMPA's regulatory guidance, the company has submitted a "Medical Device Recall Event Report Form" to the relevant provincial authority. Required actions include Philips notifying all affected users and dispatching field engineers to perform the necessary corrections on the faulty pressure relief valves.

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-suzhou-co-ltd/f697ee6b-76f7-4128-9e8c-71e7ebe08572/