da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
Intuitive Surgical is recalling certain Universal Surgical Manipulator arm sub-assemblies in da Vinci X and Xi Surgical Systems due to screws that may be susceptible to breaking during use.
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 system component where a mechanical failure (screw breakage) could result in loss of instrument control during surgery, posing a risk of harm. No reported injuries or illnesses are stated in the source, and the hazard is mechanical malfunction rather than a high-risk pathogen or allergen, placing it at the High level per the rubric.
Plain-English summary
Intuitive Surgical, Inc. is recalling certain Universal Surgical Manipulator arm sub-assemblies (part number 380647-xx) used in da Vinci X and da Vinci Xi Surgical Systems. The affected component contains screws in the arm sub-assembly that may be susceptible to breaking.
The da Vinci X and da Vinci Xi Surgical Systems are robotic surgical systems consisting of a Surgeon Console, Vision Cart, and Patient Cart. The Patient Cart contains four Universal Surgical Manipulators (arms) that allow surgeons to control instruments and an endoscope to perform surgical tasks. A broken screw in an arm sub-assembly could affect the proper functioning of the manipulator during surgery.
Approximately 2,781 affected manipulator sub-assemblies have been distributed worldwide. In the U.S., systems containing these components are located nationwide, and internationally in Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Healthcare providers using da Vinci X or da Vinci Xi Surgical Systems should contact Intuitive Surgical for information about identifying affected units and obtaining replacements.
The recalled product
- Product
- Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- mechanical-failure
- screw-breakage
Distribution
Distributed nationwide across the United States.