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Recall Observatory FDA recall evidence

Device product

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

Z-1325-2025

February 26, 2025

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 96345
Status
Ongoing
Classification
Class II
Quantity
439 units
Official record key
device-enforcement:Z-1325-2025

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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