# China NMPA Product Recall - Endoscopic surgical control system and accessories da Vinci Xi Surgical System

Source: https://www.globalkeysolutions.net/records/china_product_recall/intuitive-surgical-inc/d4bf14fe-09fd-46bb-97ac-3e5d0ce27ac5/
Source feed: China

> China NMPA product recall for Endoscopic surgical control system and accessories da Vinci Xi Surgical System by Intuitive Surgical, Inc. published July 02, 2025. Recall level: Level 1 Recall. Intuitive Surgical, Inc. has initiated a voluntary recall of its endoscopic surgical control system 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intuitive Surgical, Inc., a subsidiary of Fosun Medical Devices Technology (Shanghai) Co., Ltd., is voluntarily recalling its endoscopic surgical control system and accessories.
- Company Name: Intuitive Surgical, Inc.
- Publication Date: 2025-07-02
- Product Name: Endoscopic surgical control system and accessories da Vinci Xi Surgical System
- Recall Level: Level 1 Recall
- Recall Reason: Damage to the robotic arm sleeve support in the product system may cause deformation of the ball screw on the robotic arm insertion shaft, which in turn may cause the instrument holder to move along the insertion path.
- Discovering Company: Intuitive Surgical, Inc. (Shanghai) Co., Ltd.
- Manufacturing Company: Intuitive Surgical, Inc.
- Summary: Intuitive Surgical, Inc. has initiated a voluntary recall of its endoscopic surgical control system and accessories, specifically the da Vinci Xi Surgical System. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical safety concern. The recall stems from the potential for damage to the robotic arm's cannula support, which could cause deformation of the ball screw within the robotic arm insertion shaft. Such deformation poses a risk of the instrument holder moving unpredictably along its insertion path during surgical procedures. The manufacturer, Intuitive Surgical, Inc., identified this issue, prompting the voluntary recall. The NMPA has classified this as a "Recall" level event, indicating the seriousness of the potential risk. It is important to note that the specific products implicated in this recall were not imported into China. Detailed information regarding affected models, specifications, and batches is available in the accompanying "Medical Device Recall Event Report Form." This proactive measure by Intuitive Surgical underscores a commitment to patient safety and product integrity.

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