# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-co-ltd/6f685039-732f-4f7f-ade9-6219b5ae7da5/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by GE Healthcare Systems Co., Ltd. published December 10, 2018. Recall level: Level 3 Recall. GE Healthcare Systems Co., Ltd., through its entity Hangwei General Electric Medical Systems Co., Lt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare voluntarily recalls magnetic resonance imaging systems.
- Company Name: GE Healthcare Systems Co., Ltd.
- Publication Date: 2018-12-10
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 3 Recall
- Recall Reason: GE Healthcare recently learned that during internal inspections, we discovered that in some work sites, the latest version of the field software may not have been reinstalled after performing service activities requiring software reloading. GE Healthcare has received feedback regarding this issue. There have been no reports of injuries as a result of this problem. Maintaining high standards of safety and quality is our top priority, and GE Healthcare has decided to proactively recall the affected products.
- Discovering Company: GE Healthcare Systems Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Co., Ltd.
- Summary: GE Healthcare Systems Co., Ltd., through its entity Hangwei General Electric Medical Systems Co., Ltd., initiated a voluntary Class III recall of various Magnetic Resonance Imaging (MRI) systems. This action was published by the National Medical Products Administration (NMPA) on December 10, 2018. The recall stems from internal inspections by GE Healthcare, which uncovered that the most recent field software version might not have been reinstalled on some systems following service activities that necessitated software reloading. Affected models, including Brivo MR355, Optima MR360, and Signa EXCITE 0.2T, impact 315 units sold in China, as well as units in other countries like Canada and Japan. While no patient injuries have been reported, the company is proactively addressing the issue to uphold safety and quality standards. The required actions involve sending direct email notifications to customers about the software discrepancy and deploying GE Healthcare engineers to conduct complimentary on-site repairs for all identified affected products.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-co-ltd/27bc1958-bd73-4564-8d35-b75441e53ccf/