# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/bab1427d-7166-414b-9ce0-5b4782b07114/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by Siemens Healthineers Co., Ltd. published March 18, 2019. Recall level: Level 3 Recall. On March 18, 2019, the National Medical Products Administration (NMPA) announced a Class III volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its magnetic resonance imaging (MRI) systems.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2019-03-18
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 3 Recall
- Recall Reason: The aim is to reduce the probability of persistent steady-state mode loss of quality (PMQ).
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On March 18, 2019, the National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Siemens Healthineers for its magnetic resonance imaging (MRI) systems. The affected products, registered under Certificate No. 20153283844, include specific models (OR105 and OR122 magnets) equipped with thermoacoustic oscillation dampers.

Siemens Healthineers reported that these dampers are installed on the mentioned MRI system magnets with the intent to reduce the likelihood of continuous steady-state mode quench (PMQ). While the document does not explicitly state a malfunction of the dampers, the voluntary recall indicates a proactive measure taken by the company to address potential concerns or risks associated with the effectiveness or performance related to PMQ mitigation in these systems. This action falls under the regulatory oversight of the NMPA, which governs medical devices in China.

The company's required action is a voluntary Class III recall of the affected MRI systems, signifying a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information on the specific models, specifications, and batches involved in this recall is available in the "Medical Device Recall Event Report Form" attachment provided by Siemens Healthineers. This measure underscores the company's commitment to product safety and compliance with medical device regulations.

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/