Intuitive Surgical recalls Da Vinci X and Xi surgical systems with model IS4000/IS4200 due to potential broken screws in manipulator arms, which could cause injury during surgery.
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Intuitive Surgical is recalling Da Vinci X and Xi surgical systems with model numbers IS4000 and IS4200 because screws in the manipulator arms might break. This could lead to injury during surgery if the robotic arms malfunction.
The manipulator arms contain screws that could break during surgery. If the arms break, they might cause injury to the patient or the surgical team by moving unpredictably or malfunctioning.
Surgical teams using Da Vinci X or Xi systems with model numbers IS4000 or IS4200 are most at risk. Patients undergoing surgery with these systems may face injury if the manipulator arms break.
Check for model numbers IS4000 or IS4200 on the Da Vinci X or Xi surgical systems. The affected part has a specific part number 380647-xx for the Universal Surgical Manipulator.
Look for model numbers IS4000 or IS4200 on the surgical system to determine if it is affected.
Reach out to Intuitive Surgical directly for guidance on next steps if the system is affected.
The recall is due to screws in the manipulator arms potentially breaking, which could cause injury during surgery.
Check the model number on your system. If it's IS4000 or IS4200, contact Intuitive Surgical for further instructions.
The recall record does not specify a fix or remedy; the manufacturer recommends checking with them directly.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2046-2026 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2046-2026 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
