Intuitive Surgical recalls Patient Cart Part 380601 for da Vinci SP Surgical System Model SP1098. Inadequately welded belts may cause tissue injuries or pinching injuries to the user during surgery.
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Intuitive Surgical is recalling a specific part of the da Vinci SP Surgical System that could cause internal tissue injuries or pinching injuries to the user during surgery. This part is part of the system used in surgical procedures.
The Patient Cart part 380601 has belts that may not be welded properly. This can lead to internal tissue injuries or body wall injuries for the patient, or cause pinching injuries to the surgical staff without harming the patient.
Surgical teams using the da Vinci SP Surgical System Model SP1098 with the specific Patient Cart part number 380601 are affected. The risk is highest for surgical staff who handle the system during procedures.
Check if your da Vinci SP Surgical System Model SP1098 includes Patient Cart part 380601 with serial numbers listed in the recall notice. The part number is 380601 and the system model is SP1098.
Verify if your da Vinci SP Surgical System Model SP1098 includes Patient Cart part 380601 with the listed serial numbers.
Patient Cart part 380601, a component of the da Vinci SP Surgical System Model SP1098.
Inadequately welded belts may cause internal tissue injuries or body wall injuries to the patient, or pinching injuries to the surgical staff without harming the patient.
Check if your da Vinci SP Surgical System Model SP1098 includes Patient Cart part 380601 with serial numbers listed in the recall notice.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2024 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1518-2024 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.
