da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an...
FDA Device Recall #Z-0925-2020 — Class II — July 26, 2019
Recall Summary
| Recall Number | Z-0925-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 26, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 123 surgical systems |
Product Description
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Reason for Recall
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wisconsin and countries of Belgium, Brazil, France, Germany, India, Ireland, Italy, Japan, Norway, Panama, Poland, South Korea, Spain, Taiwan, and United Kingdom
Lot / Code Information
System Serial # PSC Serial # VSC Serial # SK2462 692049 Not Affected SK2463 Not Affected 1000895 SK2465 Not Affected 675320 SK2466 Not Affected 675528 SK2467 Not Affected 675321 SK2469 Not Affected 682124 SK2470 Not Affected 1000896 SK2474 Not Affected 674258 SK2476 Not Affected 1000894 SK2477 Not Affected 1000213 SK2478 Not Affected 1000124 SK2479 Not Affected 674257 SK2484 Not Affected 1000126 SK2485 Not Affected 1000215 SK2487 Not Affected 675322 SK2488 Not Affected 1000125 SK2490 Not Affected 676708 SK2491 Not Affected 676422 SK2492 Not Affected 677214 SK2493 Not Affected 676302 SK2494 Not Affected 679521 SK2495 Not Affected 1000214 SK2496 Not Affected 677215 SK2497 Not Affected 677877 SK2498 Not Affected 677414 SK2499 Not Affected 679892 SK2501 Not Affected 679951 SK2502 Not Affected 678360 SK2503 686019 685985 SK2504 Not Affected 677412 SK2543 Not Affected 681770 SK2544 Not Affected 683012 SK2545 692981 685078 SK2546 Not Affected 677594 SK2547 Not Affected 677879 SK2548 Not Affected 682192 SK2549 Not Affected 682123 SK2550 689635 689243 SK2552 Not Affected 686498 SK2553 691232 690199 SK2554 685520 686495 SK2555 686904 686496 SK2556 690760 690197 SK2557 688472 688040 SK2558 690762 690198 SK2559 Not Affected 686499 SK2560 Not Affected 685988 SK2563 Not Affected 681648 SK2564 689634 689239 SK2565 Not Affected 679893 SK2566 692046 691668 SK2567 692048 692608 SK2569 688473 688466 SK2571 683702 682639 SK2572 685521 687292 SK2573 690763 691667 SK2575 687380 Not Affected SK2577 Not Affected 689240 SK2578 687831 688830 SK2579 Not Affected 686497 SK2505 Not Affected 678508 SK2506 Not Affected 677591 SK2508 Not Affected 677592 SK2509 Not Affected 676705 SK2510 Not Affected 676706 SK2511 Not Affected 675527 SK2512 Not Affected 677880 SK2513 Not Affected 679894 SK2514 684738 Not Affected SK2515 Not Affected 675526 SK2517 Not Affected 675529 SK2518 Not Affected 682193 SK2520 Not Affected 682640 SK2521 Not Affected 682641 SK2522 688474 683008 SK2523 693426 695331 SK2524 687361 1000906 SK2525 Not Affected 681660 SK2526 686018 685498 SK2527 686017 685079 SK2529 686520 685501 SK2530 Not Affected 678697 SK2531 Not Affected 679525 SK2532 687362 685987 SK2534 687407 686885 SK2535 686903 687289 SK2536 685523 687288 SK2537 687828 687290 SK2538 685522 685986 SK2539 Not Affected 681756 SK2542 Not Affected 688039 SK2580 689161 688467 SK2581 Not Affected 680719 SK2582 687830 687812 SK2583 687829 687811 SK2584 689636 689617 SK2585 692978 Not Affected SK2588 695346 694227 SK2589 693427 693655 SK2590 684170 682913 SK2592 Not Affected 686886 SK2593 696642 691240 SK2594 692979 694237 SK2595 689566 688817 SK2597 689162 688831 SK2598 692620 688469 SK2599 Not Affected 688468 SK2600 693908 697864 SK2601 Not Affected 695332 SK2602 686518 686884 SK2603 693904 Not Affected SK2604 Not Affected 676157 SK2605 698331 699147 SK2607 Not Affected 693399 SK2608 693905 697865 SK2609 693902 700074 SK2611 699377 Not Affected SK2612 700989 700400 SK2619 Not Affected 683691 SK2626 702764 705065 SK2627 706894 703175 SK2629 700440 Not Affected SK2739 Not Affected 698307
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
| Z-1096-2026 | Class II | da Vinci SP, SP Access Port Kit, Large Incisio... | Dec 15, 2025 |
| Z-1134-2026 | Class II | Brand Name: Ion Endoluminal System Product Nam... | Dec 4, 2025 |
| Z-1428-2026 | Class II | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/... | Nov 17, 2025 |
| Z-1232-2026 | Class II | Brand Name: Da Vinci Product Name: da Vinci X,... | Nov 7, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.