Reported Feb 12, 2020 · Terminated
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical…
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 Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
da Vinci Xi Surgical System Surgical SystemIS400000886874114216 -
- Product Usageused with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures
- Lot codes and dates
- 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 AffectedNot Affected 686499 SK2560 Not Affected 685988 SK2563 Not Affected 681648 SK2564 689634 689239 SK2565 Not Affected
686498SK2553691232690199SK2554685520686495SK2555686904686496SK2556690760690197SK2557688472688040SK2558690762690198SK2559
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 Affected679893SK2566692046691668SK2567692048692608SK2569688473688466SK2571683702682639SK2572685521687292SK2573690763691667SK2575687380
Not Affected682641SK2522688474683008SK2523693426695331SK25246873611000906SK2525
Not Affected 678697 SK2531 Not Affected681660SK2526686018685498SK2527686017685079SK2529686520685501SK2530
Not Affected 681756 SK2542 Not Affected 688039 SK2580 689161 688467 SK2581 Not Affected679525SK2532687362685987SK2534687407686885SK2535686903687289SK2536685523687288SK2537687828687290SK2538685522685986SK2539
Not Affected680719SK2582687830687812SK2583687829687811SK2584689636689617SK2585692978
Not AffectedSK2588695346694227SK2589693427693655SK2590684170682913SK2592
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 Affected686886SK2593696642691240SK2594692979694237SK2595689566688817SK2597689162688831SK2598692620688469SK2599
Not Affected SK2612 700989 700400 SK2619 Not Affected693399SK2608693905697865SK2609693902700074SK2611699377
Not Affected SK2739 Not Affected 698307683691SK2626702764705065SK2627706894703175SK2629700440
- 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
- Amount recalled
- 123 surgical systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
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.
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