Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
da Vinci X (IS4200) and Xi (IS4000) systems Recalled by Intuitive Surgical, Inc. Due to Inadvertent energy delivery from surgical system instrument if...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.
Affected Products
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Quantity: 162
Why Was This Recalled?
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
Where Was This Sold?
This product was distributed to 27 states: AL, AK, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NV, NC, OH, PA, SC, TN, TX, WA, WI
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report