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