# China NMPA Product Recall - Mobile C-arm X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-ge-healthcare-co-ltd/9c508b4b-2f7a-4ec1-a3fd-c11b9e11b1b4/
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray machine by Beijing GE Healthcare Co., Ltd. published September 29, 2016. Recall level: Level 2 Recall. Beijing GE Healthcare Co., Ltd. initiated a voluntary Class II recall of its mobile C-arm X-ray mach

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing GE Healthcare Equipment Co., Ltd. is voluntarily recalling its mobile C-arm X-ray machine.
- Company Name: Beijing GE Healthcare Co., Ltd.
- Publication Date: 2016-09-29
- Product Name: Mobile C-arm X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: GE Healthcare recently discovered a potential malfunction in the circuit boards controlling the movement of the C-arm in this batch of equipment, which could cause unexpected movement of the C-arm. During surgery, if the C-arm moves downwards unexpectedly or collides with other medical equipment, it could lead to soft tissue injury.
- Discovering Company: Beijing GE Healthcare Co., Ltd.
- Manufacturing Company: Beijing GE Healthcare Co., Ltd.
- Summary: Beijing GE Healthcare Co., Ltd. initiated a voluntary Class II recall of its mobile C-arm X-ray machines, specifically models Brivo OEC 715 and Brivo OEC 785. This action was publicly reported by the National Medical Products Administration (NMPA) on September 29, 2016, following the company's internal report on September 22, 2016. The core issue involves a potential malfunction in the circuit board controlling the C-arm's movement, which could lead to unexpected motion. This uncontrolled movement poses a risk of soft tissue injury if it occurs during surgical procedures or results in collisions with other medical equipment. Although no injuries have been reported to date, the recall encompasses devices distributed in China, the USA, and the European Economic Area/Switzerland. Under the NMPA's regulatory framework, Beijing GE Healthcare is taking corrective actions, including directly notifying customers via email about the issue and providing essential guidance on the safe operation of the affected products. This demonstrates a proactive approach to ensure patient safety and compliance with medical device standards.

Company: https://www.globalkeysolutions.net/companies/beijing-ge-healthcare-co-ltd/81b8f648-b549-4e0a-ae4e-0bdf363fe37e/