# China NMPA Product Recall - Neuromodulation device programmable controller

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/77b5cb21-fcdd-44d1-9daf-e5ccb6b9d497/
Source feed: China

> China NMPA product recall for Neuromodulation device programmable controller by Medtronic Inc. published September 15, 2023. Recall level: Level 3 Recall. Medtronic Inc. and its subsidiary, Medtronic (Shanghai) Management Co., Ltd., have initiated a volun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling the programmable controllers for its neuromodulation devices.
- Company Name: Medtronic Inc.
- Publication Date: 2023-09-15
- Product Name: Neuromodulation device programmable controller
- Recall Level: Level 3 Recall
- Recall Reason: The clinical physician programmable tablet PC has been registered on the development server, not the production server, and is intended for Medtronic personnel to use only for product demonstrations.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. and its subsidiary, Medtronic (Shanghai) Management Co., Ltd., have initiated a voluntary Class III recall of their neuromodulation device programmer. This action, reported by the National Medical Products Administration (NMPA) on September 15, 2023, addresses a significant compliance issue. The core problem involved a clinical physician programmer tablet computer that was incorrectly registered on a development server, rather than the appropriate production server. Critically, this device was intended solely for product demonstrations by Medtronic personnel and not for clinical application. The regulatory framework governing this recall falls under the NMPA, with the affected product holding National Medical Device Registration Certificate No. 20192120588. A Class III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. As a required action, Medtronic is recalling the affected neuromodulation device programmer to mitigate any potential risks associated with its improper registration and intended use. Further specifics regarding the affected product models, specifications, and batch numbers are detailed in the "Medical Event Report Form" provided by the company. This recall underscores the importance of stringent adherence to regulatory protocols in medical device manufacturing and deployment.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/