Intuitive Surgical recalls da Vinci Xi (IS4000) and X (IS4200) surgical systems with loose Universal Surgical Manipulator carriage due to manufacturing defects. Affected units have specific serial numbers.
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Intuitive Surgical is recalling da Vinci Xi (IS4000) and X (IS4200) surgical systems because the Universal Surgical Manipulator carriage may become loose due to a manufacturing defect. This could potentially cause the system to malfunction during surgery.
The Universal Surgical Manipulator (USM) instrument carriage may become loose because the linear rail component wasn't manufactured to specifications. This could cause the system to malfunction during surgery, potentially affecting the precision of surgical instruments.
Surgical teams using the da Vinci Xi (IS4000) or X (IS4200) systems with specific serial numbers listed in the recall. Surgeons and surgical staff are most at risk if the system malfunctions during procedures.
Check if your da Vinci Xi system has serial number IS4000 or da Vinci X system has serial number IS4200 from the list provided in the recall. The affected units have specific serial numbers listed in the document.
Identify your da Vinci Xi (IS4000) or X (IS4200) system's serial number to confirm if it's in the affected list.
Reach out to Intuitive Surgical directly for guidance on next steps if your system is affected.
The recall is due to the Universal Surgical Manipulator (USM) instrument carriage being loose because the linear rail component wasn't manufactured to specifications.
Da Vinci Xi Surgical System Model IS4000 and da Vinci X Surgical System Model IS4200 with specific serial numbers listed in the recall.
No, but you should check if your system is affected and contact Intuitive Surgical for guidance if it is.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1293-2023 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1293-2023 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.
