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U.S. Department of Health and Human Services

Class 2 Device Recall Da Vinci 5

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 Class 2 Device Recall Da Vinci 5see related information
Date Initiated by FirmApril 24, 2026
Date PostedJune 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2310-2026
Recall Event ID 98569
510(K)NumberK232610 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
ProductBrand 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 by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
Code Information Lot Code: Part Number: 380746 UDI: 00886874119662 FDA Medical Device Listing Number: D531324 (U.S.) Part Number: 470653-01 Serial Numbers: 1008007 1008008 1008009 1008010 1008011 1008012 1008013 1008015 1008016 1008017 1008020 1008021 1008022 1008024 1008100 1008101 1008102 1008104 1008105 1008107 1008108 1008109 1008112 1008113 1008114 1008115 1008116 1008117 1008997 1008998 1009902 1010029 1010033 1010034 1010036 1010272 1010296 1010297 1010318 1010319 1010449 1010450 1010451 1010496 1010497 1010498 1010499 1010501 1010581 1010618 1010619 1010620 1010621 1010633 1010634 1010635 1010636 1010638 1010640 1010642 1010643 1010644 1010645 1010646 1011333 1011334 1011335 1011336 1011337 1011338 1011340 1011362 1011363 1011364 1011366 1011370 1011371 1011372 1011374 1011377 1011378 1011379 1011380 1011381 1011382 1011383 1011384 1011386 1011388 1011389 1011390 1011391 1011392 1011393 1011394 1011395 1011396 1012056 1012057 1012058 1012059 1012060 1012062 1012063 1012064 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FEI Number 3001675293
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactShahbaz Khan
1-408-5232443
Manufacturer 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.
FDA Determined
Cause 2		Device 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 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
Quantity in Commerce1357 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, Romania, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NAY
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