# China NMPA Product Recall - Implantable Spinal Cord Neurostimulation System

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-devices/594bde45-3173-4304-80f4-786b73a95397/
Source feed: China

> China NMPA product recall for Implantable Spinal Cord Neurostimulation System by Abbott Medical Devices published August 04, 2023. Recall level: Level 3 Recall. Abbott Medical Products (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its Impl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical initiates voluntary recall of implantable spinal cord stimulators.
- Company Name: Abbott Medical Devices
- Publication Date: 2023-08-04
- Product Name: Implantable Spinal Cord Neurostimulation System
- Recall Level: Level 3 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: Abbott Medical Products (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its Implantable Spinal Cord Neurostimulation System. This significant action was formally reported to the National Medical Products Administration (NMPA) on August 4, 2023. The core issue precipitating this recall involves a critical malfunction where the system's controller is unable to consistently connect or establish communication with the implanted pulse generator (IPG) while operating in MRI mode. This specific operational failure poses potential risks to patients, as it could compromise the system's functionality during an MRI scan, a common and often necessary diagnostic procedure. The affected device, identified by National Medical Device Registration Certificate No. 20213120264, is part of a voluntary recall initiated by the manufacturer to address this deficiency. The regulatory framework under which this recall is conducted is governed by the NMPA, which is responsible for safeguarding public health by overseeing medical device quality and safety in China. Abbott Medical Products (Shanghai) Co., Ltd. is taking the required action of a voluntary recall to mitigate potential patient harm and ensure that its products meet stringent safety and performance standards. Detailed information regarding the specific product models, specifications, and batch numbers involved is contained within the "Medical Device Recall Event Report Form" officially submitted to the NMPA. This proactive measure by Abbott is crucial for maintaining confidence in medical devices and ensuring patient well-being.

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