# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/98c032ee-d4d9-4f23-8afb-a049e46d2a07/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by Siemens Healthineers Co., Ltd. published February 13, 2019. Recall level: Level 3 Recall. Siemens Healthineers initiated a voluntary Class III recall of its Magnetic Resonance Imaging System

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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: 2019-02-13
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 3 Recall
- Recall Reason: Due to regulatory changes, the original labels on the equipment will need to be replaced with new product labels. The new product labels include the agent's name, address and contact information, as well as the expiration date.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: Siemens Healthineers initiated a voluntary Class III recall of its Magnetic Resonance Imaging Systems (MRI Systems) on February 13, 2019, as reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by regulatory changes that necessitated an update to the product labels. Specifically, the original labels on the equipment required replacement with new versions that include essential information such as the agent's name, address, contact details, and product expiration date. This action ensures compliance with the updated regulatory framework. Affected products include MRAs with specific registration certificate numbers (CFDA (Imported) 2014 No. 3282943, CFDA (Imported) 20153283844, CFDA (Imported) 2014 No. 3284816). Detailed information regarding the affected models and batches is available in the company's Medical Device Recall Report Form. Siemens Healthineers' proactive measure addresses the labeling discrepancy to meet current regulatory standards.

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