# China NMPA Product Recall - Endoscopic surgical control system and accessories

Source: https://www.globalkeysolutions.net/records/china_product_recall/intuitive-surgical-inc/768ef472-051a-42ed-a676-0ba5e724ac8b/
Source feed: China

> China NMPA product recall for Endoscopic surgical control system and accessories by Intuitive Surgical, Inc. published September 19, 2019. Recall level: Level 2. Intuitive Surgical, Inc., in conjunction with its subsidiary Intuitive Fosun Medical Device Technolo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intuitive Surgical, Inc. is voluntarily recalling its endoscopic surgical control system and accessories.
- Company Name: Intuitive Surgical, Inc.
- Publication Date: 2019-09-19
- Product Name: Endoscopic surgical control system and accessories
- Recall Level: Level 2
- Recall Reason: There are potential faults in the printed circuit board assembly.
- Discovering Company: Intuitive Fosun Medical Devices Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Intuitive Surgical, Inc.
- Summary: Intuitive Surgical, Inc., in conjunction with its subsidiary Intuitive Fosun Medical Device Technology (Shanghai) Co., Ltd., announced a voluntary Class II recall for its Endoscopic Surgical Control Systems and associated accessories. This action was reported on September 19, 2019, under the oversight of the National Medical Products Administration (NMPA) of China. The primary reason for the recall is the identification of a potential malfunction within the product's printed circuit board assembly. This issue has the potential to affect the system's operational integrity and patient safety. The recall encompasses specific models, specifications, and batches of the affected devices, with detailed information available in the "Medical Device Recall Event Report Form." As a Class II recall, the NMPA indicates that the issue could lead to temporary or medically reversible adverse health consequences, or that serious consequences are remote. Intuitive Surgical, Inc. is responsible for implementing corrective actions, which include retrieving affected products from the market and ensuring full compliance with NMPA regulations to address the identified defect and maintain product quality and patient safety standards.

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