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U.S. Department of Health and Human Services

Class 3 Device Recall da Vinci Vision System Cart

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  Class 3 Device Recall da Vinci Vision System Cart see related information
Date Initiated by Firm October 21, 2013
Date Posted November 04, 2013
Recall Status1 Terminated 3 on September 04, 2014
Recall Number Z-0146-2014
Recall Event ID 66570
510(K)Number K081137  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product da Vinci Vision System Cart, a component of the
da Vinci Si Surgical System IS3000;
Y1903 Illuminator (Illuminator + Lamp Module);
Y1902 Replacement Lamp Modules.

Intuitive Surgical, Sunnyvale, CA.

As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, handheld, as with a traditional endoscopy cart) or can be mounted on the camera arm to assist with preoperative exploration. Also integrated in the Vision System Cart is the Illuminator. The illuminator has a single light source attached to the endoscopy assembly by the light guide cable. It provides illumination inside the body for vision of the surgical field. The Illuminator monitors the life left on the lamp module and notifies the customer when replacement is recommended.
Code Information Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing. Serial numbers: 11K1903D7944 11K1903D7949 11K1903D7950 11K1903D7951 11K1903D7952 11K1903D7953 11K1903D7954 11L1903D7989 11L1903D7990 11L1903D7991 11L1903D7992 11L1903D7993 11L1903D7994 11L1903D7995 11L1903D7996 11L1903D7997 11L1903D7998 11L1903D7999 11L1903D8000 11L1903D8001 11L1903D8002 11L1903D8003 11L1903D8004 11L1903D8005 11L1903D8006 11L1903D8007 11L1903D8008 11L1903D8009 11L1903D8010 11L1903D8011 11L1903D8012 11L1903D8013 11L1903D8014 11L1903D8015 11L1903D8016 11L1903D8017 11L1903D8018 11L1903D8019 11L1903D8020 11L1903D8021 11L1903D8022 11L1903D8023 11L1903D8024 11L1903D8025 11L1903D8026 11L1903D8027 11L1903D8028 11L1903D8029 11L1903D8030 11L1903D8031 11L1903D8032 11L1903D8033 11L1903D8034 11L1903D8035 11L1903D8036 11L1903D8037 11L1903D8038 11L1903D8039 11L1903D8040 11L1903D8041 11L1903D8042 11L1903D8043 11L1903D8044 11L1903D8045 11L1903D8046 11L1903D8047 11L1903D8048 11L1903D8049 11L1903D8050 11L1903D8051 11L1903D8052 11M1903D8078 11M1903D8079 11M1903D8080 11M1903D8081 11M1903D8082 11M1903D8083 11M1903D8084 11M1903D8085 11M1903D8086 11M1903D8087 11M1903D8088 11M1903D8089 11M1903D8090 11M1903D8091 11M1903D8092 11M1903D8093 11M1903D8094 11M1903D8095 11M1903D8096 11M1903D8097 11M1903D8098 11M1903D8099 11M1903D8100 11M1903D8101 11M1903D8102 11M1903D8103 11M1903D8104 11M1903D8105 11M1903D8106 11M1903D8107 11M1903D8108 11M1903D8109 11M1903D8127 11M1903D8128 11M1903D8129 11M1903D8130 11M1903D8131 11M1903D8132 11M1903D8133 11M1903D8134 11M1903D8135 11M1903D8136 11M1903D8137 11M1903D8138 11M1903D8139 11M1903D8140 11M1903D8141 11M1903D8142 11M1903D8143 11M1903D8144 11M1903D8145 11M1903D8146 11M1903D8147 11M1903D8148 11M1903D8149 11M1903D8150 11M1903D8151 11M1903D8152 11M1903D8153 11M1903D8154 11M1903D8155 11M1903D8156 11M1903D8157 11M1903D8158 12A1903D8292 12A1903D8293 12A1903D8294 12A1903D8295 12A1903D8296 12A1903D8297 12A1903D8298 12A1903D8299 12A1903D8300 12A1903D8301 12A1903D8302 12A1903D8303 12A1903D8304 12A1903D8305 12A1903D8306 12A1903D8307 12A1903D8308 12A1903D8309 12A1903D8310 12A1903D8311 12A1903D8312 12A1903D8313 12A1903D8314 12A1903D8315 12A1903D8316 12A1903D8317 12A1903D8318 12A1903D8319 12A1903D8320 12A1903D8321 12A1903D8322 12A1903D8323 12A1903D8346 12A1903D8347 12A1903D8348 12A1903D8349 12A1903D8350 12A1903D8351 12A1903D8352 12A1903D8353 12A1903D8354 12A1903D8355 12A1903D8356 12A1903D8357 12A1903D8358 12A1903D8359 12A1903D8360 12A1903D8361 12B1903D8418 12B1903D8419 12B1903D8420 12B1903D8421 12B1903D8422 12B1903D8423 12B1903D8424 12B1903D8425 12B1903D8426 12B1903D8427 12B1903D8428 12B1903D8429 12B1903D8430 12B1903D8431 12B1903D8432 12B1903D8433 12C1903D8434 12C1903D8435 12C1903D8436 12C1903D8437 12C1903D8438 12C1903D8439 12C1903D8440 12C1903D8441 12C1903D8442 12C1903D8443 12C1903D8444 12C1903D8445 12C1903D8446 12C1903D8447 12C1903D8448 12C1903D8449 12C1903D8478 12C1903D8479 12C1903D8480 12C1903D8481 12C1903D8482 12C1903D8483 12C1903D8484 12C1903D8485 12C1903D8486 12C1903D8487 12C1903D8488 12C1903D8489 12C1903D8490 12C1903D8491 12C1903D8492 12C1903D8493 12C1903D8519 12C1903D8520 12C1903D8521 12C1903D8522 12C1903D8523 12C1903D8524 12C1903D8525 12C1903D8526 12C1903D8527 12C1903D8528 12C1903D8529 12C1903D8530 12C1903D8531 12C1903D8532 12C1903D8533 12C1903D8534 12D1903D8573 12D1903D8574 12D1903D8575 12D1903D8576 12D1903D8577 12D1903D8578 12D1903D8579 12D1903D8580 12D1903D8581 12D1903D8582 12D1903D8583 12D1903D8584 12D1903D8585 12D1903D8586 12D1903D8587 12D1903D8588 12D1903D8589 12D1903D8590 12D1903D8591 12D1903D8592 12D1903D8593 12D1903D8594 12D1903D8595 12D1903D8596 12D1903D8597 12D1903D8598 12D1903D8599 12D1903D8600 12D1903D8601 12D1903D8602 12D1903D8603 12D1903D8604 12D1903D8681 12D1903D8682 12D1903D8683 12D1903D8684 12D1903D8685 12D1903D8686 12D1903D8687 12D1903D8688 12D1903D8689 12D1903D8690 12D1903D8691 12D1903D8692 12D1903D8693 12D1903D8694 12D1903D8695 12D1903D8696 12E1903D8729 12E1903D8730 12E1903D8731 12E1903D8732 12E1903D8733 12E1903D8734 12E1903D8735 12E1903D8736 12E1903D8737 12E1903D8738 12E1903D8739 12E1903D8740 12E1903D8741 12E1903D8742 12E1903D8743 12E1903D8744.  Y1902 (PN 950093-05) Replacement lamp module with coated housing; Serial numbers: 1HJD9411 1HJD9412 1HJD9415 1HJD9421 1HJD9422 1HJD9424 1HJD9465 1HJD9466 1HJD9467 1HJD9469 1HJD9470 1HJD9472 1HJD9473 1HJD9474 1HJD9475 1HJD9476 1HJD9477 1HJD9478 1HJD9483 1HJD9498 1KJD1554 1KJD1555 1KJD1556 1KJD1557 1KJD1558 1KJD1559 1KJD1560 1KJD1561 1KJD1562 1KJD1563 1KJD1564 1KJD1565 1KJD1566 1KJD1579 1KJD1580 1KJD1581 1KJD1582 1KJD1583 1KJD1584 1KJD1586 1KJD1588 1KJD1589 1KJD1590 1KJD1591 1KJD1592 1KJD1593 1KJD1594 1KJD1595 1KJD1596 1KJD1597 1KJD1599 1KJD1600 1KJD1601 1KJD1602 1KJD1603 1KJD1604 1KJD1605 1KJD1606 1KJD1607 1KJD1609 1KJD1626 1KJD1627 1LJD1831 1LJD1832 1LJD1833 1LJD1834 1LJD1836 1LJD1837 1LJD1839 1LJD1840 1LJD1841 1LJD1842 1LJD1845 1LJD1846 1LJD1847 1LJD1850 1LJD1852 1LJD1853 1LJD1854 1LJD1855 1LJD1856 1LJD1858 1LJD1859 1LJD1861 1LJD1862 1LJD1863 1LJD1864 1LJD1865 1LJD1866 1LJD1867 1LJD1868 1LJD1869 1LJD1872 1LJD1873 1LJD1874 1LJD1875 1LJD1876 1LJD1877 1LJD1878 1LJD1879 1LJD1881 1LJD1882 1LJD1883 1LJD1884 1LJD1886 1LJD1887 1LJD1888 1LJD1889 1LJD1891 1LJD1892 1LJD1893 1LJD1894 1LJD1895 1LJD1897 1LJD1898 1LJD1899 1LJD1901 1LJD1903 1LJD1904 1LJD1905 1LJD1906 1LJD1907 1LJD1908 1LJD1909 1LJD1911 1LJD1912 1LJD1916 1LJD1917 1LJD1918 1LJD1919 1LJD1921 1LJD1922 1LJD1923 1LJD1924 1LJD1925 1LJD1926 1LJD1927 1LJD1928 1LJD1929 1LJD1930 1LJD1931 1LJD1932 1LJD1933 1LJD1935 1LJD1936 1LJD1937 1LJD1938 1LJD1939 1LJD1941 1LJD1942 1LJD1943 1LJD1944 1LJD1945 1LJD1946 1LJD1947 1LJD1948 1LJD1949 1LJD1950 1LJD1952 1LJD1953 1LJD1954 1LJD1955 1LJD1956 1LJD1957 1LJD1958 1LJD1959 1LJD1960 1LJD1961 1LJD1962 1LJD1963 1LJD1964 1LJD1966 1LJD1967 1LJD1968 1LJD1969 1LJD1970 1LJD1971 1LJD1972 1LJD1973 1LJD1974 1LJD1975 1LJD1976 1LJD1977 1LJD1978 1LJD1979 1LJD1980 1MJD2854 1MJD2855 1MJD2856 1MJD2858 1MJD2859 1MJD2862 1MJD2863 1MJD2864 1MJD2865 1MJD2866 1MJD2867 1MJD2868 1MJD2869 1MJD2870 1MJD2871 1MJD2872 1MJD2873 1MJD2874 1MJD2876 1MJD2877 1MJD2878 1MJD2879 1MJD2880 1MJD2881 1MJD2882 1MJD2884 1MJD2885 1MJD2886 1MJD2888 1MJD2889 1MJD2891 1MJD2893 1MJD2896 1MJD2908 1MJD2909 1MJD2910 1MJD2911 1MJD2912 1MJD2913 1MJD2914 1MJD2915 1MJD2916 1MJD2917 1MJD2919 1MJD2920 1MJD2921 1MJD2922 1MJD2923 1MJD2924 1MJD2925 1MJD2926 1MJD2927 1MJD2928 1MJD3005 1MJD3007 1MJD3008 1MJD3009 1MJD3011 1MJD3012 1MJD3014 1MJD3016 1MJD3017 1MJD3021 1MJD3022 1MJD3023 1MJD3025 1MJD3027 1MJD3028 1MJD3029 1MJD3030 1MJD3031 1MJD3033 1MJD3034 1MJD3035 1MJD3037 1MJD3042 2AJD3454 2AJD3455 2AJD3457 2AJD3459 2AJD3460 2AJD3461 2AJD3462 2AJD3463 2AJD3465 2AJD3466 2AJD3467 2AJD3468 2AJD3469 2AJD3471 2AJD3472 2AJD3476 2AJD3477 2AJD3480 2AJD3481 2AJD3484 2AJD3485 2AJD3489 2AJD3491 2AJD3492 2AJD3493 2AJD3494 2AJD3495 2AJD3496 2AJD3497 2AJD3498 2AJD3500 2AJD3501 2AJD3502 2AJD3503 2AJD3504 2AJD3505 2AJD3506 2AJD3507 2AJD3508 2AJD3509 2AJD3510 2AJD3511 2AJD3512 2AJD3513 2AJD3518 2AJD3524 2AJD3526 2AJD3528 2AJD3533 2AJD3534 2AJD3535 2AJD3536 2AJD3537 2AJD3538 2AJD3539 2AJD3541 2AJD3542 2AJD3543 2AJD3544 2AJD3545 2AJD3546 2AJD3547 2AJD3548 2AJD3549 2AJD3550 2AJD3551 2AJD3552 2AJD3558 2AJD3559 2AJD3561 2AJD3562 2AJD3563 2AJD3564 2AJD3566 2AJD3567 2AJD3568 2AJD3569 2AJD3570 2AJD3572 2AJD3573 2AJD3575 2AJD3576 2AJD3578 2AJD3579 2AJD3580 2AJD3581 2AJD3582 2AJD3583 2AJD3584 2AJD3588 2AJD3589 2AJD3609 2AJD3612 2AJD3613 2AJD3614 2AJD3615 2BJD4398 2BJD4399 2BJD4400 2BJD4401 2BJD4402 2BJD4404 2BJD4406 2BJD4408 2BJD4409 2BJD4412 2BJD4413 2BJD4415 2BJD4416 2BJD4425 2BJD4426 2BJD4428 2BJD4431 2BJD4432 2BJD4433 2BJD4434 2BJD4435 2BJD4436 2BJD4437 2BJD4438 2BJD4439 2BJD4440 2BJD4441 2BJD4443 2BJD4444 2BJD4445 2BJD4446 2BJD4448 2BJD4449 2BJD4450 2BJD4451 2BJD4452 2BJD4453 2BJD4454 2BJD4455 2BJD4456 2BJD4457 2BJD4473 2BJD4474 2BJD4475 2BJD4476 2BJD4477 2BJD4490 2BJD4538 2BJD4539 2BJD4540 2BJD4541 2BJD4542 2BJD4543 2BJD4544 2BJD4545 2BJD4546 2BJD4547 2BJD4548 2BJD4549 2BJD4550 2BJD4551 2BJD4552 2BJD4553 2BJD4554 2BJD4555 2BJD4557 2BJD4579 2BJD4580 2BJD4581 2BJD4582 2BJD4583 2BJD4584 2BJD4585 2BJD4586 2BJD4587 2BJD4588 2BJD4589 2BJD4590 2BJD4591 2BJD4592 2BJD4593 2BJD4594 2BJD4595 2BJD4596 2BJD4597 2BJD4619 2BJD4620 2BJD4622 2BJD4623 2BJD4624 2BJD4625 2BJD4627 2BJD4628 2BJD4629 2BJD4630 2BJD4631 2BJD4632 2BJD4633 2BJD4634 2BJD4635 2BJD4677 2BJD4678 2BJD4679 2BJD4680 2BJD4681 2BJD4682 2BJD4683 2BJD4686 2BJD4687 2BJD4688 2BJD4689 2BJD4690 2BJD4691 2BJD4718 2BJD4719 2BJD4722 2BJD4723 2BJD4750 2BJD4752 2BJD4753 2BJD4754 2BJD4755 2CJD4897 2CJD4898 2CJD4899 2CJD4902 2CJD4903 2CJD4906 2CJD4909 2CJD4910 2CJD4911 2CJD4912 2CJD4913 2CJD4948 2CJD4950 2CJD4951 2CJD4953 2CJD4954 2CJD4955 2CJD4957 2CJD4958 2CJD4959 2CJD4960 2CJD4961 2CJD4963 2CJD4964 2CJD4975 2CJD4976 2CJD4979 2CJD4980 2CJD4981 2CJD4982 2CJD4983 2CJD4984 2CJD4985 2CJD4987 2CJD4988 2CJD4989 2CJD4990 2CJD4991 2CJD4992 2CJD5038 2CJD5051 2CJD5700 2CJD5743 2CJD5755 2CJD5760 2CJD5762. 
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
Manufacturer Reason
for Recall
Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Intuitive Surgical sent an Urgent Medical Device Correction letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to open the illuminator and replace any metal-finish lamp modules with plastic finish lamp modules, if customers do not have a replacement plastic-finish lamp module available, they may continue to use the metal-finish lamp module until they receive a replacement. If the message "illuminator lamp module error: Please reseat or replace lamp module" is displayed on the patient side monitor and the surgeon console, contact intuitive Surgical Customer Service. Customers were also instructed to examine any remaining or spare inventory to identify any metal-finish lamp modules and return them to Intuitive Surgical for credit. Customers were instructed to ensure all affected personnel are fully informed of this Urgent Medical Device Corrrection letter. Customers should complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. Customers with questions should contact Intuitive Surgical Customer Service. For questions regarding this recall call 408-523-2244.
Quantity in Commerce Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Israel, Italy, Mexico, Monaco, Netherlands, Norway, Pakistan, Panama, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, South Korea, Sweden, Switzerland, Taiwan, and Turkey.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.