Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000
See all recalls from Intuitive Surgical, Inc. →Recalled Product
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
Hazard / Issue
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.
Issued by
FDA
Affected States: 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Lot/Code Info: 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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✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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