# China NMPA Product Recall - Neuromodulation device programmer, spinal cord nerve stimulator doctor programming system, patient programmer

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/ad77c045-2202-4fc8-adf1-b0e13b2ec223/
Source feed: China

> China NMPA product recall for Neuromodulation device programmer, spinal cord nerve stimulator doctor programming system, patient programmer by Medtronic Inc. published September 15, 2023. Recall level: Level 2 Recall. Medtronic Inc., via its Medtronic (Shanghai) Management Co., Ltd. entity, has initiated a voluntary 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling neuromodulation device programmers, spinal stimulator physician programming systems, and patient programmers.
- Company Name: Medtronic Inc.
- Publication Date: 2023-09-15
- Product Name: Neuromodulation device programmer, spinal cord nerve stimulator doctor programming system, patient programmer
- Recall Level: Level 2 Recall
- Recall Reason: The updated A710 CP application (v2.0.136) is incompatible with the existing A901 Communication Manager application (v1.0.1169), causing the A710 sequence to be unable to communicate with implantable neurostimulators (INS)/wireless external neurostimulators (WENS).
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., via its Medtronic (Shanghai) Management Co., Ltd. entity, has initiated a voluntary Level II recall of specific neuromodulation device programmers and spinal neurostimulator physician programming systems. This action, publicly released by the National Medical Products Administration (NMPA) on September 15, 2023, addresses a critical software incompatibility. The issue arises because an updated A710 CP application (v2.0.136) cannot properly communicate with implantable and wireless external neurostimulators (INS/WENS) due to its incompatibility with the existing A901 Communication Manager application (v1.0.1169). This technical conflict prevents the devices from functioning as intended. The affected products include the spinal cord stimulator physician programming system, physician programming device, and neuromodulation device programming device, all operating under NMPA medical device registration. Medtronic is taking this voluntary action within the NMPA's regulatory guidelines. The immediate required action is the recall of these devices to prevent potential patient safety risks associated with communication failures, with detailed product information available in the attached recall report.

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