Intuitive Surgical recalls da Vinci Xi Endoscope Controller (model IS4000) due to dim, color-imbalanced surgical images and potential fogging. Affected units have specific model and serial numbers.
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
Intuitive Surgical is recalling the da Vinci Xi Endoscope Controller (model IS4000) because it may show dim, color-unbalanced surgical images and cause increased fogging during Firefly imaging. This could affect surgical accuracy and patient outcomes.
The Endoscope Controller may show dimmer images, have color imbalance, or reduced fluorescence and grayscale when using Firefly imaging. This could lead to increased fogging of the endoscope, potentially affecting surgical precision.
Surgical teams using the da Vinci Xi system with the specific model and serial numbers are affected. Patients undergoing surgery with this controller may be at risk of less precise imaging.
Check for the model name 'IS4000' and serial number 'SK1703' on the device. The product was sold with model number 372601-16 and UDI number 00886874114193.
Look for the model name 'IS4000' and serial number 'SK1703' on the device.
The Endoscope Controller may have improper calibration during manufacturing, causing dim, color-imbalanced images and potential fogging during Firefly imaging.
Check for the model name 'IS4000' and serial number 'SK1703' on the device. The product was sold with model number 372601-16 and UDI number 00886874114193.
The recall record does not specify a remedy, so contact Intuitive Surgical directly for guidance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2835-2018 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2835-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
