Devices

Device Recall Lumenis

  • 모델명 / 제조번호(시리얼번호)
    All codes manufactured prior to November 4, 2003.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. The product was released for distribution to 1431 consignees worldwide. International consignees include: Australia, Canada, India, Netherlands, Argentina, France, Malaysia, Italy, Brazil, Mexico, China, Colombia, Thailand, Holland, Japan, and Venezuela. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • 제품 설명
    Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; || Manufactured before November 4, 2003; || Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104
  • Manufacturer
    Lumenis Inc.
  • 1 Event

제조사

Lumenis Inc.
  • 제조사 주소
    Lumenis Inc., 2400 Condensa St, Santa Clara CA 95051-0901
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

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Device Recall Lumenis VersaCut Tissue Morcellator
  • 모델명 / 제조번호(시리얼번호)
    GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
  • 제품 설명
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 || The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
  • Manufacturer
    Lumenis
Device Recall Lumenis M22 System
  • 모델명 / 제조번호(시리얼번호)
    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) All Acne Filters manufactured and Distributed Between: August 04 2015 and November 06 2015
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.
  • 제품 설명
    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
  • Manufacturer
    Lumenis Ltd
Device Recall Lumenis
  • 모델명 / 제조번호(시리얼번호)
    All codes, All serial numbers
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
  • 제품 설명
    Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; || Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
  • Manufacturer
    Lumenis Inc.
Device Recall Lumenis
  • 모델명 / 제조번호(시리얼번호)
    Lot/Batch Numbers:   37600206, 38030206, 38470206, 39110306, 39660406, 40480506, 41040506, 42110606, 42550706, 37640206, 38120206, 38480206, 39200306, 39670406, 40490506, 41050506, 42120606, 42560706, 37650206, 38150206, 38510206, 39210306, 39680406, 40520506, 41080506, 42200606, 42570706, 37660206, 38160206, 38520206, 39220306, 39690406, 40530506, 41090506, 42210606, 42580706, 37700206, 38170206, 38530206, 39240306, 39770406, 40570506, 41100506, 42280606, 42650706, 37710206, 38200206, 38700306, 39250306, 39800406, 40580506, 41210506, 42290606, 42680706, 37720206, 38210206, 38710306, 39260306, 39810406, 40590506, 41310506, 42300606, 42740706, 37730206, 38230206, 38720306, 39270306, 39820406, 40600506, 41360506, 42310606, 42810706, 37740206, 38240206, 38730306, 39280306, 39830406, 40610506, 41390506, 42320606, 42890706, 37750206, 38300206, 38740306, 39460306, 39840406, 40690506, 41450506, 42330606, 43000706, 37760206, 38310206, 38800306, 39470306, 39880406, 40710506, 41470506, 42350606, 43010706, 37770206, 38380206, 38810306, 39530306, 39890406, 40720506, 41500506, 42360606, 43060706, 37800206, 38390206, 38830306 39540306, 39900406, 40730506, 41610606, 42380606, 43150706, 37810206, 38400206, 38840306, 39550306, 40180406, 40930506, 41750606, 42410606, 43190706, 37820206, 38410206, 38920306, 39560306, 40200406, 40940506, 41880606, 42420606, 43200706, 37890206, 38420206, 38930306, 39570306, 40340406, 40960506, 41890606, 42430606, 43210706, 37910206, 38430206, 38970306 39580306, 40390406, 40970506, 41900606, 42460706, 43220706, 37960206, 38440206, 38980306, 39590306, 40430406, 40980506, 41930606, 42490706, 43270706, 37970206, 38450206, 38990306, 39600306, 40460506, 41020506, 41990606, 42500706, 43280706, 37980206, 38460206, 39000306, 39650306, 40470506, 41030506, 42000606, 42540706, 43410706
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.
  • 제품 설명
    Lumenis brand DuoTome SideLite¿ 550 Micron Delivery System; laser systems for ablating soft tissue. || Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
  • Manufacturer
    Lumenis Inc.