# China NMPA Product Recall - Mobile O-arm X-ray machine O-arm O2 Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-navigation-inc-littleton/a9b301cb-ba2d-45f5-beb5-dae260194fe6/
Source feed: China

> China NMPA product recall for Mobile O-arm X-ray machine O-arm O2 Imaging System by Medtronic Navigation, Inc (Littleton) published June 11, 2025. Recall level: Level 2 Recall. Medtronic Navigation, Inc. (Littleton), a medical device manufacturer, has initiated a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Navigation, Inc. (Littleton) is voluntarily recalling its mobile O-arm X-ray machines.
- Company Name: Medtronic Navigation, Inc (Littleton)
- Publication Date: 2025-06-11
- Product Name: Mobile O-arm X-ray machine O-arm O2 Imaging System
- Recall Level: Level 2 Recall
- Recall Reason: A mechanical component in a specific batch of products may be damaged during the system manufacturing process, potentially causing intermittent jamming or noise during use, thereby compromising the system's integrity.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Navigation, Inc (Littleton)
- Summary: Medtronic Navigation, Inc. (Littleton), a medical device manufacturer, has initiated a voluntary Class II recall of its O-arm O2 Imaging System, known as mobile O-arm X-ray machines. This action was reported by Medtronic (Shanghai) Management Co., Ltd. to the National Medical Products Administration (NMPA) on June 11, 2025. The recall addresses a critical manufacturing issue involving potential damage to a mechanical component within a specific batch of these X-ray machines. This defect could cause intermittent jamming or unusual noise during operation, thereby compromising the device's integrity and reliability. The O-arm O2 Imaging System holds National Medical Device Registration Certificate No. 20183060139, issued under NMPA's regulatory framework. While this is a global recall, the NMPA document confirms that the particular batch of products involved was not imported into China. As a required action, Medtronic Navigation, Inc. is actively recalling the affected devices. Detailed information, including specific models, specifications, and batch numbers, is available in the accompanying "Medical Device Recall Event Report Form," highlighting the company's proactive approach to patient safety and product quality.

Company: https://www.globalkeysolutions.net/companies/medtronic-navigation-inc-littleton/18e75e72-fead-4ac5-8bed-c0c928b44b46/