ClearanceBrief
Recall Z-2310-2026 ยท NAY System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc.

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied b

DateJun 4, 2026 (initiated Apr 24, 2026)
StatusOpen, Classified
ReasonDue to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Root causeDevice Design
ActionOn 04/24/2026, the firm emailed an "Urgent Medical Device Correction" Letter to customers informing them that Intuitive has identified a condition in which the NIR modes may remain active unintentionally when attempting to turn off visible white light illumination during normal clinical workflow transitions, when switching from the handheld camera to the robotic endoscope and may result in thermal injury if the distal end of the light guide (detached) or assembled laparoscope contacts the patient, user, or sterile drapes while NIR mode is active. Customer Actions required for Continued Use of
Quantity1357 systems
DistributionU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
Intuitive Surgical, Inc., Mar 14, 2024