PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 19, 2025 Initiated: February 26, 2025 #Z-1325-2025

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

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
439 units
Distribution
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.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Intuitive Surgical, Inc.. Units affected: 439 units.
Why was this product recalled?
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Which agency issued this recall?
This recall was issued by the FDA Devices on March 19, 2025. Severity: Moderate. Recall number: Z-1325-2025.