Intuitive Surgical recalls da Vinci Xi Endoscope Controller Model 372601-16 due to improper calibration causing potential thermal tissue injury and overly bright images during surgery.
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Intuitive Surgical is recalling a specific endoscope controller used in their da Vinci surgical system because it was improperly calibrated during servicing. This could cause the endoscope tip to overheat, potentially injuring tissue or creating overly bright images during surgery.
The endoscope controller was improperly calibrated during servicing, which can cause the tip of the endoscope to reach higher temperatures. This may lead to thermal tissue injury or produce overly bright images during surgery.
Surgical teams using the da Vinci Xi Endoscope Controller Model 372601-16 with the IS 4000 Vision Cart are affected. Surgeons and surgical technicians who use this specific model are most at risk.
Check for the model number 372601-16 on the endoscope controller. The product is included in the IS 4000 Vision Cart with model number 381121-31.
Verify if the endoscope controller has been properly calibrated by contacting Intuitive Surgical directly.
No, this recall specifically affects the da Vinci Xi Endoscope Controller Model 372601-16 with the IS 4000 Vision Cart.
Contact Intuitive Surgical directly to check if your controller needs recalibration.
The recall states that improper calibration may cause thermal tissue injury, so it is recommended to verify calibration status with Intuitive Surgical.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0283-2021 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0283-2021 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.
