Da Vinci 5 surgical console foot pedals recalled for spring failure
Intuitive Surgical has recalled 439 Da Vinci 5 surgical console foot tray pedals due to spring failures that can cause pedals to remain pressed and interfere with normal surgical robot operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical robot control component. While no injuries or illnesses have been reported, a failed foot pedal on surgical equipment represents a significant risk of harm during procedures.
Plain-English summary
Intuitive Surgical, Inc. is recalling 439 Da Vinci 5 surgical console foot tray pedal assemblies (Model 380730) due to a mechanical defect in the foot tray pedal spring.
The foot tray pedals are control components of the Da Vinci 5 robotic surgical system used during surgical procedures. The recalled units have experienced spring failures that result in pedals remaining in a pressed position, which could interfere with proper console operation during surgery.
The affected units were manufactured prior to December 20, 2024, and were distributed worldwide, including throughout the United States and South Korea.
Hospitals and surgical centers using the Da Vinci 5 system should contact Intuitive Surgical for replacement units or repair instructions. The recalled units can be identified by UDI 00886874119747.
The recalled product
- 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
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- spring-failure
- pedal-malfunction
Distribution
Distributed nationwide across the United States.
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