United StatesThe da Vinci Xi, da Vinci X, and da Vinci 5 robotic surgical systems (model/catalog numbers IS4000, IS4200, IS5000 and affected units listed by UDI and serial numbers) are included in this recall. They were recalled because a software implementation error allowed instrument arms that failed a diagnostic test to remain in clinical use; the test is intended to detect bent or misaligned insertion axis ball screws that can precede ball screw fatigue failure/fracture. Owners should check whether their system serial numbers or UDIs match the affected product list.
What's being recalled
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the 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…
Recalling firm: Intuitive Surgical, Inc., Sunnyvale, CA, United States.
How to identify it
Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 See attachment Affected Product List UDI: 00886874114216 FDA Medical Device Listing Number: D295931 See attachment Affected Product List UDI: 00886574119747 FDA Medical Device Listing Number: D531324 See attachment Affected Product List da Vinci Xi (U.S.) USM Serial Numbers / System Serial Numbers: 402229 SK0835 766250 SK2180 797416 SK3689 674366 SK0095 453952 SK0135 10200891 RSK8057 675618 SK3649 634899 SK2504 440133 SK0682 362922 SK6006 405421 SK0449 390728 SK0389 608999 SK2328 395840 SK0523 368190 SK0837 441220 SK0909 596758 SK5711 474567 SK0075 376348 RSK8009 468435 SK1448 586220 SK5354 417890 SK2763 620604 SK2121 454704 SK1314 601085 SK4517 360714 SK2497 502409 SK0480 450881 SK1012 374877 SK2478 614195 SK1155 10012820 SK2135 685557 SK2489 575597 SK5978 432486 SK3140 624939 SK4316 357017 SK0157 448370 SK0959 432785 SK1380 552202 SK4752 801777 SK3600 598141 SK1967 653902 SK0048 791279 SK5269 392895 SK0992 423997 SK1265 10130883 SK5682 10345574 SK0756 609316 SK0756 643879 SK1802 721374 SK2851 721385 SK2851 721390 SK2851 726207 SK2851 423127 SK0159 453587 SK0159 789074 SK0159 803938 SK3632 808928 SK3632 811477 SK3632 405752 SK0886 821001 SK3749 821012 SK3749 821018 SK3749 396587 SK0448 396835 SK0448 396956 SK0448 539536 SK0448 10201501 SK2573 364250 SK2573 389078 SK2573 10581505 SK8006 10591492 SK8006 10592026 SK8006 10592897 SK8006 10397285 SK7337 10398002 SK7337 10403504 SK7337 626074 SK7337 682234 SK2552 684029 SK2552 557855 SK1374 558304 SK1374 678245 SK1374 783025 SK3579 803627 SK3579 806689 SK3579 807816 SK3579 10143148 SK2686 457566 SK2686 673397 SK2686 951895 SK4542 957596 SK4542 959481 SK4542 959484 SK4542 662812 SK2351 662935 SK2351 663327 SK2351 946051 SK4628 972693 SK4628 973277 SK4628 973278 SK4628 785070 SK3363 785071 SK3363 786266 SK3363 448204 SK0152 703938 SK0152 574265 SK0159 592288 SK1817 560902 SK1913 537160 SK1913 459654 SK1913 556989 SK3209 729789 SK3209 731745 SK3209…
The hazard
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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan and United Kingdom
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)