Surgical Robot Instrument Carriage Loose Due to Manufacturing Defect
Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a manufacturing defect creating risk of instrument carriage looseness during surgical procedures. Without reported illnesses or injuries, this fits the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,225 Universal Surgical Manipulator (USM) instrument carriages for da Vinci Xi Surgical System (Model IS4000) and da Vinci X Surgical System (Model IS4200). The instrument carriage can become loose during use as a result of the linear rail component not being manufactured within specifications.
The affected systems have been distributed in the United States and internationally, including Austria, Belgium, China, India, Japan, and many other countries worldwide.
Healthcare facilities and surgical teams currently using these systems should inspect the instrument carriage and contact Intuitive Surgical for replacement components. Any concerns about the safety or performance of a da Vinci system should be reported to the manufacturer immediately.
The recalled product
- Product
- da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,225
Distribution
Distributed in 1 state:
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