Reported Jun 10, 2026 · Ongoing
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Brand NameDa
- Vinci 5 Product NameASSY,DV5 TOWER
- IS5000 Model/Catalog Number380746
- Software VersionN/A
- Product DescriptionPreface: 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 DescriptionThe 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
- ComponentYes, the SOCK is the component and integrated into the dV5 system
- Lot codes and dates
- Lot CodePart
- Number380746
- UDI00886874119662
- FDA Medical Device Listing NumberD531324 (U.S.)
- Part Number470653-01
- Serial Numbers
1,080 of 1,080 codes
100800710080081008009100801010080111008012100801310080151008016100801710080201008021100802210080241008100100810110081021008104100810510081071008108100810910081121008113100811410081151008116100811710089971008998100990210100291010033101003410100361010272101029610102971010318101031910104491010450101045110104961010497101049810104991010501101058110106181010619101062010106211010633101063410106351010636101063810106401010642
- Part Number470653-03
- Serial Numbers(O.U.S.)
203 of 203 codes
118613611861391157705115770611577211161015116101711610281161029116103011610561161064116106611610671161068116106911610701161071116107311610741161075116107611610771161078116108011610811161082116114911611501164405116440711644281164449116445011644551164456116446411644651164466116451911645201164522116452311645241164525116452611645271164528116453011645311164532116453311645371164541116454511645491164550116626711662681166269
- Part Number470653-01
- Serial Numbers
101403310140351014142101415710141611014162102677710267781026785102805510280811028084104379910438001043801104382110438951043898104599810460521047715104771711377381137745114056211405691140584114058911405911140592
- Part Number470653-03
- Serial Numbers
11791961161059116893111710681159334115775011577481166282115775311710211168936116105311577581164454116446711593271159259115932911577021157757115933111645481157759116106011863841171066116107911577561159330116445711593281168966115933511644061157751116896911662661161054116895111593261159332115932411571201166283
- Amount recalled
- 1357 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Intuitive Surgical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.