# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-japan-corporation/82987d52-394e-49df-930b-ea30904bc9bf/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by GE Healthcare Japan Corporation published August 29, 2016. Recall level: Level II. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. voluntarily recalls magnetic resonance imaging systems.
- Company Name: GE Healthcare Japan Corporation
- Publication Date: 2016-08-29
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level II
- Recall Reason: Within a small area on the inner wall of the magnet, the temperature generated under certain scanning conditions may pose a risk to patients in direct contact or without padding. GE has not received any reports of injury without this issue. This problem only occurs in this area when it is frequently used for peri-central scanning of large, heavy patients (e.g., off-central shoulder examination) while the radiofrequency emission gain is near its maximum.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Japan Corporation
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Discovery MR750w 3.0T Magnetic Resonance Imaging Systems. This action, reported to the National Medical Products Administration (NMPA) on June 8, 2016, and publicly announced on August 29, 2016, addresses a patient safety concern. The company identified that under specific scanning conditions, a small area on the magnet's inner wall can generate elevated temperatures. This poses a thermal injury risk to patients who directly contact the magnet or do not use appropriate padding. The issue primarily occurs during frequent peri-central scanning of large-weight patients, such as off-central shoulder joint examinations, especially when the radiofrequency transmit gain is near its maximum setting. Affected products were distributed globally, including in the USA, Australia, Canada, and China. As corrective measures, GE Healthcare committed to notifying customers via letter, providing guidance on safe operation, and dispatching engineers to conduct free, on-site repairs for all identified affected systems.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-japan-corporation/1255c781-b3b7-457c-978d-5dad8ae35b78/