# China NMPA Product Recall - Implantable Spinal Cord Neurostimulation System

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-devices/286b5312-de2f-4b31-9b7f-11253e25f0e1/
Source feed: China

> China NMPA product recall for Implantable Spinal Cord Neurostimulation System by Abbott Medical Devices published September 19, 2023. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) has announced a significant recall initiated by 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical has issued a recall for its implantable spinal cord stimulator.
- Company Name: Abbott Medical Devices
- Publication Date: 2023-09-19
- Product Name: Implantable Spinal Cord Neurostimulation System
- Recall Level: Level 1 Recall
- Recall Reason: The controller is unable to connect to or establish communication with the implanted pulse generator (IPG) in MRI mode.
- Discovering Company: Abbott Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Medical Devices
- Summary: The National Medical Products Administration (NMPA) has announced a significant recall initiated by Abbott Medical. On September 19, 2023, the NMPA publicized that Abbott Medical Products (Shanghai) Co., Ltd. is voluntarily recalling its Implantable Spinal Cord Neurostimulation System. This action stems from a critical malfunction where the system's controller is unable to establish or maintain communication with the implanted pulse generator (IPG) when operating in MRI mode. This recall, initially reported on August 4, 2023, has been escalated from a Level III to a Level I recall, indicating the highest potential for serious adverse health consequences or death. Abbott Medical, as the manufacturer, is responsible for this voluntary action under the regulatory oversight of the NMPA. The specific models, specifications, and batch numbers of the affected devices are detailed in the accompanying "Medical Device Recall Event Report Form." This situation highlights the importance of device reliability, particularly in critical medical applications and when interacting with other medical imaging technologies. The NMPA's involvement ensures public awareness and regulatory compliance in managing this serious product safety concern.

Company: https://www.globalkeysolutions.net/companies/abbott-medical-devices/febfa01e-9e15-4f25-8627-6d8bd96868aa/