Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci ...
Reason for Recall / 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
Product Description & Identification
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, 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. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Affected Products
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, 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. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98050 |
| Address 1 | 1266 Kifer Rd |
| Address 2 | N/A |
| Code info | 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 SK... [TRUNCATED] |
| Postal code | 94086-5304 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 219 |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251107 |
| Initial firm notification | Letter |
| Center classification date | 20260202 |
Overview
- Recalling FirmIntuitive Surgical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.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