# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-anke-high-tech-co-ltd/5e29f197-9658-4e56-876a-d4aec73e0b88/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by Shenzhen Anke High-Tech Co., Ltd. published June 07, 2021. Recall level: Level 3 Recall. Shenzhen Anke High-Tech Co., Ltd. initiated a voluntary Level III recall of its Magnetic Resonance I

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Anke High-Tech Co., Ltd. voluntarily recalls magnetic resonance imaging systems
- Company Name: Shenzhen Anke High-Tech Co., Ltd.
- Publication Date: 2021-06-07
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 3 Recall
- Recall Reason: Due to changes in the product category catalog, the registration certificate number in the instruction manual was not updated in a timely manner during the renewal registration process.
- Discovering Company: Shenzhen Anke High-Tech Co., Ltd.
- Manufacturing Company: Shenzhen Anke High-Tech Co., Ltd.
- Summary: Shenzhen Anke High-Tech Co., Ltd. initiated a voluntary Level III recall of its Magnetic Resonance Imaging Systems, a regulatory action publicized by the National Medical Products Administration (NMPA) on June 7, 2021. The primary issue necessitating this recall was a documentation error: the registration certificate number within the product's instruction manual was not updated during the renewal registration process. This oversight occurred in response to changes in the national product classification catalog, indicating a lapse in maintaining up-to-date regulatory documentation rather than a performance or safety defect of the device itself. Operating under the oversight of the NMPA, reported through the Guangdong Provincial Drug Administration, the company's required action is to conduct a voluntary recall of all identified affected batches, models, and specifications of the MRI systems. A Level III recall typically indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. This specific situation emphasizes the critical importance for medical device manufacturers to ensure all associated documentation, including instruction manuals, accurately reflects current regulatory approvals and classifications to maintain compliance with the NMPA's standards. Shenzhen Anke High-Tech Co., Ltd. has provided detailed information on the scope of the recall in an accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/shenzhen-anke-high-tech-co-ltd/92b5d6dc-4633-4e83-82e0-0827232304fe/