Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product De

FDA device recall Z-2310-2026 · posted 2026-06-04 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Due 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.

Action taken

On 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 dV5 Systems Equipped with the NIR Handheld Camera: "Prior to each use, ensure that the NIR Handheld Camera Light Source indicators remain visible to operating room staff so that the laser status can be confirmed. Position the dV5 Tower Monitor and other equipment so the Light Source indicators are not obstructed from view. "The Tower Monitor should be positioned to avoid obstructing the Light Source indicators to maintain clear visibility of the CCU during use. Monitor positioning may vary based on Operating Room configuration. Refer to the Near Infrared Handheld Camera System User Manual (PN 557076-02) for additional setup guidance. "The indicators include: - LASER ON status indicator -Laser symbol on the LCD display -Green-colored button backlights "Prior to placing the device on the patient or sterile drapes, confirm that the Light Source is in Standby Mode, as indicated by white-colored button backlights and Standby on the LCD display. "Press and hold the green up arrow button on the Camera Head for approximately 2.5 seconds to deactivate the light source. "Be aware of the following Cautions stated in the Handheld Camera Light Guide IFU (Schoelly s reference: TPA801-460-01; Intuitive s reference: PN 557072-01): For questions/support, Clinical Sales Rep or Intuitive Customer Service at the numbers listed below: "North and South America: (800) 876-1310, Option 3 (4 am

Root cause

Device Design

Status

Open, Classified

Product code

NAY

Quantity affected

1357 systems

Distribution

U.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, an

Date initiated

2026-04-24

Date posted

2026-06-04

Location

Sunnyvale, CA

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