# China NMPA Product Recall - Ion Endoluminal System (Bronchial Navigation Operation Control System)

Source: https://www.globalkeysolutions.net/records/china_product_recall/intuitive-surgical-inc/5a4c6505-8064-4651-8c8b-f673fd5cd331/
Source feed: China

> China NMPA product recall for Ion Endoluminal System (Bronchial Navigation Operation Control System) by Intuitive Surgical, Inc. published July 02, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on July 2, 2025, a voluntary Level II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intuitive Surgical, Inc. is voluntarily recalling its bronchial navigation operation control system.
- Company Name: Intuitive Surgical, Inc.
- Publication Date: 2025-07-02
- Product Name: Ion Endoluminal System (Bronchial Navigation Operation Control System)
- Recall Level: Level 2 Recall
- Recall Reason: Screws in a specific batch did not meet relevant standards.
- Discovering Company: Intuitive Fosun Medical Devices Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Intuitive Surgical, Inc.
- Summary: The National Medical Products Administration (NMPA) announced on July 2, 2025, a voluntary Level II recall initiated by Intuitive Surgical, Inc. This recall concerns their Ion Endoluminal System, specifically the Bronchial Navigation Operation Control System. The local entity, Intuitive Fosun Medical Device Technology (Shanghai) Co., Ltd., reported the issue, which stems from a critical manufacturing flaw: screws in a particular batch of the product failed to meet the required quality standards. A Level II recall signifies a situation where potential health consequences from product use are temporary or medically reversible, or the probability of serious adverse effects is remote. Importantly, the specific batch of products involved in this recall was not imported into the Chinese market. Detailed information regarding affected models, specifications, and batch numbers is available in the accompanying Recall Event Report Form. This action by Intuitive Surgical, Inc., under the NMPA's regulatory oversight, underscores the commitment to maintaining stringent product quality and ensuring patient safety within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/intuitive-surgical-inc/02e7ab6e-a4d4-46fc-9c87-8b4d958db04d/