# China NMPA Product Recall - Intraoperative EEG/EMG/evoked potential measurement system, disposable surgical electrodes, disposable neurostimulation probe

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-xomed-inc/15b85260-a740-4715-8aee-866ea66cb5d5/
Source feed: China

> China NMPA product recall for Intraoperative EEG/EMG/evoked potential measurement system, disposable surgical electrodes, disposable neurostimulation probe by Medtronic Xomed, Inc. published January 30, 2019. Recall level: Level 3 Recall. Medtronic Xomed, Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., voluntarily init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Xomed, Inc. is voluntarily recalling three products, including disposable surgical electrodes.
- Company Name: Medtronic Xomed, Inc.
- Publication Date: 2019-01-30
- Product Name: Intraoperative EEG/EMG/evoked potential measurement system, disposable surgical electrodes, disposable neurostimulation probe
- Recall Level: Level 3 Recall
- Recall Reason: Our company discovered that expanders, electrodes, and probes sterilized by Xian Friendship Medical Electronics Company, Ltd. and shipped to Japan were subject to a recall because Xian Friendship Medical Electronics' address change was not registered with the MHLW in Japan. Furthermore, Xian Friendship Medical Electronics had actually changed the sterilization site from the original external supplier to an internal control site. Therefore, we initiated a proactive recall to notify our Japanese customers and applied for the corresponding address change.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Xomed, Inc.
- Summary: Medtronic Xomed, Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., voluntarily initiated a Class III recall for three medical products: an intraoperative EEG/EMG/evoked potential measurement system, disposable surgical electrodes, and disposable nerve stimulation probes. This recall, reported to the National Medical Products Administration (NMPA) on January 18, 2019, was prompted by an unregistered change in sterilization sites. Specifically, Xian Friendship Medical Electronics Company, Ltd., a third-party sterilizer, shifted its sterilization operations from an external supplier to an internal facility without registering this modification with the Japanese Ministry of Health, Labour and Welfare (MHLW). This regulatory non-compliance affected products sold exclusively in Japan. As a result, Medtronic proactively recalled the products in Japan, informed its Japanese customers, and initiated the necessary address change registration process. The NMPA document confirms that no further corrective actions are required in China, as the affected product batches were not distributed within the Chinese market, adhering to existing CFDA (now NMPA) import medical device registration standards.

Company: https://www.globalkeysolutions.net/companies/medtronic-xomed-inc/6ab04f9c-4587-45b0-ab74-0dfb3aa38e32/