Events

Rappel de Device Recall da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Intuitive Surgical, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73314
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1191-2016
  • Date de mise en oeuvre de l'événement
    2016-02-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143856
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System,surgical,computer controlled instrument - Product Code NAY
  • Action
    Urgent Medical Device Recall letters were sent on March 2, 2016. Letters advised users of the issue and that Intuitive Representative will visit each site to replace the affected compact flash card.

Device

Device Recall da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad
  • Modèle / numéro de série
    Model # M187505-04 - IS3000/IS4000 SCC Touchpad: IS4000 PSC Touchpad. Serial numbers: SH2188 SK0391 SK0392 SK0454 SK0569 SK0577 SK0583 SK0613 SK0686 USG642 SK0482 SH0034 SH2321 SK0321 SK0426 SK0566 SK0603 SK0614 SH2312 SH2338 SH2339 SH2341 SH2344 SH2360 SH2361 SH2362 SH0948 SH1104 SH2240 SK0648 SH2328 SH2329 SH2337 SH2342 SH2346 SH2350 SH2351 SH2352 SH2356 SH2363 SH2364 SH2365 SK0329 SK0588 SK0591 SK0428 SK0429 SK0453 SH0607 SH2340 SK0503 SK0598 SH0280 SH2331 SH2333 SH2345 SK0479 SK0499 SK0528 SK0567 SK0568 SK0584 USG122 SK0563 SK0576 SH1228 SK0447 SK0530 SK0670 SH0329 SH0881 SH2347 SH2348 SH2349 SK0089 SK0336 SK0395 SK0421 SK0517 SK0592 SK0593 SK0595 SK0596 SK0597 SH1802 SH2332 SK0305 SK0367 SK0374 SK0386 SK0388 SK0411 SK0424 SK0431 SK0462 SK0472 SK0473 SK0481 SK0520 SK0526 SK0575 SK0581 SK0586 SK0624 SK0639 SK0647 SH2318 SK0529 SK0335 SK0507 SK0632 SH0416 SK0611 SH2354 SK0460 SK0497 SK0381 SH1869 SK0405 SK0475 SK0510 SK0658 SK0407 SK0413 SK0540 SK0564 SK0565 SK0582 SK0315 SK0501 SH2313 SK0515 SK0580 SK0217 SK0318 SK0322 SH1380 SH2323 SH2326 SH2327 SH2359 SK0562 RSH0020 SD0003 SD0004 SD0005 SH0074 SH0164 SH0272 SH0473 SH0741 SH0934 SH0938 SH1011 SH1350 SH1356 SH1378 SH1394 SH1522 SH1983 SH2311 SH2315 SH2316 SH2320 SK0240 SK0281 SK0285 SK0299 SK0300 SK0301 SK0307 SK0309 SK0314 SK0317 SK0320 SK0331 SK0338 SK0339 SK0340 SK0342 SK0343 SK0346 SK0349 SK0352 SK0360 SK0372 SK0375 SK0376 SK0382 SK0383 SK0384 SK0385 SK0389 SK0390 SK0398 SK0400 SK0401 SK0402 SK0406 SK0408 SK0409 SK0412 SK0414 SK0415 SK0416 SK0417 SK0418 SK0419 SK0420 SK0423 SK0425 SK0430 SK0432 SK0433 SK0434 SK0435 SK0436 SK0437 SK0438 SK0439 SK0440 SK0441 SK0443 SK0444 SK0445 SK0446 SK0448 SK0449 SK0452 SK0455 SK0456 SK0457 SK0458 SK0459 SK0463 SK0464 SK0466 SK0467 SK0468 SK0471 SK0477 SK0478 SK0480 SK0483 SK0484 SK0485 SK0486 SK0487 SK0488 SK0489 SK0491 SK0492 SK0493 SK0494 SK0495 SK0496 SK0498 SK0500 SK0502 SK0504 SK0505 SK0506 SK0508 SK0511 SK0512 SK0513 SK0514 SK0516 SK0518 SK0519 SK0521 SK0522 SK0523 SK0524 SK0525 SK0531 SK0532 SK0533 SK0534 SK0535 SK0536 SK0537 SK0538 SK0539 SK0541 SK0542 SK0543 SK0544 SK0546 SK0547 SK0548 SK0549 SK0550 SK0551 SK0552 SK0553 SK0554 SK0555 SK0556 SK0557 SK0561 SK0570 SK0571 SK0572 SK0573 SK0574 SK0578 SK0579 SK0585 SK0589 SK0590 SK0594 SK0600 SK0606 SK0608 SK0610 SK0612 SK0619 SK0620 SK0622 SK0627 SK0629 SK0630 SK0634 SK0636 SK0637 SK0641 SK0649 SK0651 SK0652 SK0653 SK0655 SK0656 SK0659 SK0665 SK0671 SK0676 SK0678 SK0684 SK0685 USG050 USG333 USG690 SK0490 SK0688 SK0689 SK0690.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela.
  • Description du dispositif
    da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary || anastomosis during cardiac revascularization.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Adresse du fabricant
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Société-mère du fabricant (2017)
    Intuitive Surgical Inc
  • Source
    USFDA