Home / Recalls / Intuitive Surgical, Inc. / Z-1325-2025

Z-1325-2025 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

FDA device recall Z-1325-2025 was initiated by Intuitive Surgical, Inc. on February 26, 2025 and is designated Class II. Reason for recall: Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed The recall status is ongoing. Affected quantity: 439 units.

Recall Details

Product Type: Devices
Report Date: March 19, 2025
Initiation Date: February 26, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 439 units

Product Description

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

Reason for Recall

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the country of South Korea.

Code Information

UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.

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