Medical device recalls Moderate risk

Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Ver…

Recall date
February 26, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1325-2025
FDA classification
Class II
Brand / firm
Intuitive Surgical, Inc.
Sold / distributed
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, Nebr…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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