Intuitive Surgical recalls da Vinci SP Camera model 430060-33 due to residual soil on camera tips that could cause image issues or sensitization risks during surgery.
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
Intuitive Surgical is recalling da Vinci SP cameras with model number 430060-33 because some cameras have soil residue after reprocessing. This could lead to needing a second camera or switching surgical methods, and if soil contacts patients, it might cause sensitization issues for blood or tissue treatments.
Residual soil on the camera tip after reprocessing can cause image quality problems, requiring a switch to another camera or surgical method. If soil contacts patients, it might lead to sensitization issues that complicate blood or tissue treatments later.
Surgical teams using the da Vinci SP camera model 430060-33 for endoscopic procedures are most at risk, particularly if the camera is used in procedures where image quality is critical.
Check for the model number 430060-33 on the camera. All units sold with this model number are affected, including those with serial numbers starting with UDI 00886874114384.
Look for the model number 430060-33 on the camera to confirm it is affected.
Some cameras have residual soil after reprocessing that may affect image quality, potentially requiring a switch to another camera or surgical method. If soil contacts patients, it could cause sensitization issues for blood or tissue treatments.
The recall does not specify a remedy, so check with Intuitive Surgical for guidance on next steps.
The recall describes potential sensitization risks but does not mention serious injury or death, so the risk is low.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2131-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2131-2020 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.
