# China NMPA Product Recall - Inactive accessories of Intuitive Surgical da Vinci Xi Endoscopic Instrument Control System

Source: https://www.globalkeysolutions.net/records/china_product_recall/intuitive-surgical-inc/90f7cb56-f6d3-4acc-aa08-8f52ccab09c2/
Source feed: China

> China NMPA product recall for Inactive accessories of Intuitive Surgical da Vinci Xi Endoscopic Instrument Control System by Intuitive Surgical, Inc. published November 01, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on November 1, 2023, that Intuitive Su

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intuitive Surgical, Inc. is voluntarily recalling passive instruments and accessories used in endoscopic surgical instrument control systems.
- Company Name: Intuitive Surgical, Inc.
- Publication Date: 2023-11-01
- Product Name: Inactive accessories of Intuitive Surgical da Vinci Xi Endoscopic Instrument Control System
- Recall Level: Level 3 Recall
- Recall Reason: The expiration date on the brown packaging shipping box for the sterile sheath of the instrument arm is incorrect.
- Discovering Company: Intuitive Fosun Medical Devices Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Intuitive Surgical, Inc.
- Summary: The National Medical Products Administration (NMPA) announced on November 1, 2023, that Intuitive Surgical, Inc. has initiated a voluntary Level III recall of specific passive instruments and accessories associated with their da Vinci Xi Endoscopic Instrument Control System. The primary reason for this recall is the discovery of an incorrect expiration date prominently displayed on the brown packaging shipping boxes for certain sterile sleeve products, which are designed for the instrument arm. Intuitive Surgical, Inc., as the manufacturer, reported this discrepancy, prompting the proactive recall. The affected products are categorized as inactive accessories of the Intuitive Surgical da Vinci Xi Endoscopic Instrument Control System, which is registered under National Medical Device Registration Certificate 20172022398. A Level III recall classification indicates that the use of, or exposure to, the violative product is not expected to cause adverse health consequences. As a required action, Intuitive Surgical, Inc. is voluntarily removing these items from the market. Comprehensive details outlining the specific affected product models, their specifications, and corresponding batch numbers are thoroughly documented in the accompanying "Medical Device Recall Event Report Form" referenced in the NMPA's announcement. This action underscores the company's commitment to product integrity and patient safety.

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