Intuitive Surgical recalls da Vinci X and Xi surgical systems with software version P10 due to risk of unintended energy delivery causing injury if specific conditions are met.
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
Intuitive Surgical is recalling da Vinci X (IS4200) and Xi (IS4000) surgical systems because a software issue can cause unintended energy delivery from instruments during surgery. This could lead to injury if certain conditions are met, such as specific instrument connections and pedal actions.
The system can deliver unintended energy from surgical instruments if specific conditions are met: force bipolar and bipolar instruments are installed, force bipolar is connected to the generator but not the bipolar instrument, and the yellow pedal is pressed while the blue pedal is pressed. This could cause injury during surgery.
Surgical teams using da Vinci X or Xi systems with software version P10 are affected. Surgeons and surgical staff are most at risk due to the potential for unintended energy delivery during procedures.
Check for da Vinci X (IS4200) or Xi (IS4000) systems with software version P10 (OS4 v10.0.0/A70_P10_B738). The model numbers include 610092-738, 380652-55, and others listed in the recall notice.
Verify the software version on your system; affected units have version P10 (OS4 v10.0.0/A70_P10_B738).
Reach out to Intuitive Surgical for guidance on next steps and potential remedies.
The hazard is unintended energy delivery from surgical instruments if force bipolar and bipolar instruments are installed, force bipolar is connected to the generator but not the bipolar instrument, and the yellow pedal is pressed while the blue pedal is pressed.
Check for da Vinci X (IS4200) or Xi (IS4000) systems with software version P10 (OS4 v10.0.0/A70_P10_B738). Model numbers include 610092-738, 380652-55, and others listed in the recall notice.
Contact Intuitive Surgical for guidance on next steps and potential remedies. The recall does not include a specific remedy like a repair or replacement.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0133-2023 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0133-2023 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.
