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 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

Class II

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.
Affected products (lot / model / serial): 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 1012065 1012066 1012068 1012069 1012070 1012071 1012073 1012075 1012076 1012078 1012079 1012080 1012081 1012082 1012084 1012085 1012284 1012998 1012999 1013001 1013002 1013003 1013004 1013005 1013007 1013008 1013009 1013010 1013011 1013012 1013013 1013015 1013017 1013019 1013108 1013109 1013110 1013111 1013112 1013113 1013114 1013115 1013116 1013117 1013118 1013119 1013120 1013121 1013122 1013124 1013125 1013126 1013127 1013129 1013130 1013132 1013491 1013492 1013493 1013494 1013496 1013497 1014027 1014028 1014029 1014030 1014031 1014032 1014034 1014036 1014037 1014038 1014039 1014140 1014143 1014146 1014147 1014149 1014150 1014151 1014152 1014153 1014154 1014155 1014156 1014158 1014159 1014160 1014163 1014164 1014165 1014166 1014167 1014168 1014169 1014170 1014171 1014173 1014174 1014175 1014177 1014178 1014574 1014575 1014576 1014577 1014578 1014580 1014581 1014582 1014583 1014584 1014585 1014586 1014587 1014589 1014590 1014591 1014592 1014594 1014595 1014596 1014597 1014598 1014599 1014600 1014601 1014602 1014603 1014604 1014605 1014606 1014607 1014608 1014609 1014610 1014611 1014612 1014613 1014615 1014616 1014618 1014619 1014622 1014623 1014624 1014721 1014722 1014723 1014724 1014725 1014726 1014727 1014728 1014729 1014730 1014731 1015247 1015248 1015250 1015251 1015252 1015253 1015254 1015255 1015256 1015257 1015258 1015259 1015260 1015261 1015262 1015263 1015264 1015266 1015854 1015855 1016110 1016111 1016112 1016113 1016114 1016115 1016117 1016118 1016119 1016120 1016122 1016123 1016124 1016125 1016126 1016127 1016128 1016129 1016130 1016136 1016137 1016138 1016139 1016140 1016141 1016142 1016143 1016144 1016150 1016151 1016152 1016153 1016154 1016155 1016475 1016478 1016479 1016480 1016481 1016482 1016483 1016484 1016601 1016602 1016603 1016604 1016605 1016606 1016607 1016608 1016791 1017181 1017182 1017327 1017328 1017329 1017330 1017331 1017332 1017333 1017334 1017336 1017337 1017338 1017340 1017341 1017343 1017345 1017346 1017347 1017348 1017545 1017547 1017549 1017550 1017552 1017553 1017555 1017556 1017557 1017558 1017560 1017561 1017562 1017565 1017566 1017569 1017570 1017571 1017572 1017573 1017867 1017871 1017873 1017874 1017875 1017878 1017879 1017880 1017882 1017884 1017887 1017888 1017890 1017891 1017893 1017894 1017895 1017896 1017898 1017899 1017900 1017902 1017903 1017904 1018075 1018076 1018108 1018109 1018110 1018111 1018112 1018114 1018146 1018148 1018150 1018151 1018152 1018153 1018194 1018195 1018196 1018197 1018198 1018199 1018256 1025415 1025416 1025417 1025418 1025419 1025420 1025421 1025427 1025433 1025434 1025435 1025436 1025437 1025438 1025439 1025440 1025442 1025443 1025444 1025716 1025717 1025718 1025719 1025720 1025721 1025722 1025723 1025724 1025725 1025726 1025727 1025728 1025729 1025730 1025731 1025732 1025733 1025734 1026046 1026047 1026048 1026049 1026051 1026052 1026770 1026771 1026772 1026773 1026774 1026775 1026776 1026779 1026780 1026781 1026782 1026783 1026784 1026786 1026787 1026788 1027960 1027961 1027962 1027963 10279
Units affected: 1357 systems
Distribution pattern: 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, 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
Firm location: Sunnyvale, CA, United States
Recall type: Voluntary: Firm initiated
Product type: Devices
Status: Ongoing
Recall number: Z-2310-2026
Recall initiated: April 24, 2026
FDA classification date: June 4, 2026
FDA report date: June 10, 2026
FDA event ID: 98569
Last updated on HTM Vibe: July 23, 2026

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