Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Error
Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of thermal tissue injury, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling one da Vinci Surgical System, IS 4000 Endoscope Controller (Model Number: 372601-16) that was improperly calibrated during servicing. The device is part of the IS 4000 Vision Cart and is used with endoscopes and surgical instruments to perform minimally invasive procedures.
The improper calibration may result in the tip of the endoscope reaching higher temperatures than intended. This condition creates a potential for thermal tissue injury to the patient and may also cause overly bright images during the procedure.
The recall affects one system distributed nationwide, including in the state of Washington. The specific unit is identified by Serial Number 432242 installed on the da Vinci Surgical System with Serial Number SK2137. Healthcare facilities should contact Intuitive Surgical for instructions on how to address the calibration issue.
The recalled product
- 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 mi
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- IS4000 Endoscope Controller
- Serial Number: 432242 installed on the da Vinci Surgical System
- Serial Number: SK2137
Distribution
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