Intuitive Surgical, Inc. da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137
Products Sold
IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137
Intuitive Surgical, Inc. is recalling da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 0088687411419 due to One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Send formal customer letter communication to the affected site. The firm reported that a representative scheduled an on-site visit to replace the affected unit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026