Reported Feb 11, 2026 · Ongoing
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:…
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 Product Nameda Vinci X, Xi Surgical System, & da Vinci 5
- Surgical System Model/Catalog Number
IS4000IS4200
- IS5000 Software VersionN/A
- Product DescriptionThe da Vinci Xi, X, and da Vinci 5 surgical systems
- each consist of three main componentsthe Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery
- ComponentThe affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
- Lot codes and dates
- Lot CodeUDI: 00886874114216
- FDA Medical Device Listing NumberD531324 See
- attachment Affected Product List UDI00886874114216
- FDA Medical Device Listing NumberD295931 See
- attachment Affected Product List UDI00886574119747
- FDA Medical Device Listing NumberD531324 See attachment Affected Product List da Vinci Xi (U.S.) USM
- Serial Numbers / System Serial Numbersda Vinci Xi (O.U.S.)
264 of 264 codes
402229SK0835766250SK2180797416SK3689674366SK0095453952SK013510200891RSK8057675618SK3649634899SK2504440133SK0682362922SK6006405421SK0449390728SK0389608999SK2328395840SK0523368190SK0837441220SK0909596758SK5711474567SK0075376348RSK8009468435SK1448586220SK5354417890SK2763620604SK2121454704SK1314601085SK4517360714SK2497502409SK0480450881SK1012374877SK2478614195SK1155
da Vinci X (O.U.S.)154 of 154 codes
10144327SK0241885500SK4083709052SK265110002413SK469510531698CX0067441442SK0934435551SK090710241998SK633210318042SK675910216387SK634110217208SK6341392890SK025610216383SK6250587895SK0950789071SK0777450418SK0388740913SK2996392885SK0129464471SK1034423008SK0658726556SK5869443119SK092510340582SK691710514694SK7706818737SK3669819530SK3669820601SK366910060417SK503210061285SK503210061291SK5032
da Vinci 5 (U.S.) USM364477SL005210233342SL1118392675SL0264593091SL017810168067SL0255686701SL0598686724SL0598689991SL0598704719SL0598
- Serial Numbers / System Serial Numbers10651060 SQ0343 da Vinci 5
- Amount recalled
- 219
Where it was sold
Why it was recalled
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
This product could cause temporary or reversible health problems — stop using it.
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