# China NMPA Product Recall - Programmable charging kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/a2b7c76f-2b04-419d-b5a3-dc5a000e290c/
Source feed: China

> China NMPA product recall for Programmable charging kit by Medtronic Inc. published November 17, 2023. Recall level: Level 2 Recall. Medtronic Inc., in collaboration with its subsidiary Medtronic (Shanghai) Management Co., Ltd., has 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its programmable charging kits.
- Company Name: Medtronic Inc.
- Publication Date: 2023-11-17
- Product Name: Programmable charging kit
- Recall Level: Level 2 Recall
- Recall Reason: Incoming material inspection revealed that some programmable controllers did not have the correct firmware installed to support the Japanese user interface, which may cause communication problems with the implanted neurostimulator (INS).
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., in collaboration with its subsidiary Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of its programmable charging kits. This action, reported on November 17, 2023, to the National Medical Products Administration (NMPA), was prompted by an internal finding during incoming material inspection. It was discovered that some programmable controllers within the kits lacked the correct firmware necessary to support the Japanese user interface. This significant oversight presents a potential risk, as it may cause communication problems with implanted neurostimulators (INS), thereby compromising device functionality. The Class II recall indicates a situation where the use of or exposure to the affected product could lead to temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Medtronic is taking the required actions to address the specific affected product models, specifications, and batches, as detailed in the accompanying Medical Device Recall Event Report Form, adhering to the NMPA's regulatory requirements.

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