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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-ge-healthcare-co-ltd/b90ffbb9-f302-4c72-a37d-0be86e4d7c6f/
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 for its mobile C-arm X-ray mac

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing GE Healthcare 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 C-arm's movement in this batch of equipment, which could cause unintended 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. To date, there have been no reports of injuries caused by this issue.
- 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 for its mobile C-arm X-ray machines, specifically models Brivo OEC 715 and Brivo OEC 785. The recall was publicly announced by the National Medical Products Administration (NMPA) on September 29, 2016, following the company's report on September 22, 2016. The primary concern stems from a potential malfunction in the circuit board responsible for controlling the C-arm's movement. This defect could lead to unexpected or uncontrolled motion of the C-arm during surgical procedures, posing a risk of collision with other medical equipment or causing soft tissue injury to patients. Fortunately, no injuries related to this issue have been reported to date. Under the NMPA's regulatory guidance, Beijing GE Healthcare's required actions include recalling the affected product batches. Furthermore, the company is implementing corrective measures by distributing emails to all customers to inform them about the identified safety concern and provide comprehensive guidance on the safe operation of the mobile C-arm X-ray machines, aiming to mitigate any potential risks and ensure patient safety.

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