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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0146-2014

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.

Publicado el 13 de noviembre de 2013 · Inicio del retiro: 21 de octubre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Intuitive Surgical, Inc.
Distribuidor
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.
Lote
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 12D1903D8
Clasificación de riesgo
Class III
Área (FDA)
device
País
United States

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