[pending] Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System M
Pending LLM rewrite. Source: FDA_DEVICE Z-1232-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
The recalled product
- Product
- Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed in 30 states:
- AL
- AR
- CA
- CO
- CT
- FL
- ID
- IL
- IN
- KS
- KY
- MD
- MI
- MN
- MO
- MS
- NC
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- TN
- TX
- UT
- VA
- WA
- WI
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