Device Recall Leica Microsystems (Schweiz) AG,

  • 모델명 / 제조번호(시리얼번호)
    OH5-51313; OH4-112214; OH5-49112; OH5-67914; OH4-101213; OH5-20238; OH4-91913; OH5-43312; OH5-54113; OH5-64514; OH4-103014; OH4-106514; OH4-87112; OH4-95413; OH4-94213; OH4-106014; OH4-105514; OH4-94813; OH4-102514; OH4-91113; OH4-87312; OH4-106714; OH5-62113; OH5-46112; OH5-50512; OH4-85912; OH4-81512; OH5-61013; OH5-53913; OH4-95013; OH4-91413; OH4-110614; OH4-94613; OH4-104714; OH4-87212; OH4-85712; OH5-50212; OH4-96213; OH4-88913; OH4-89613; OH5-55113; OH4-99413; OH5-48112; OH4-90713; OH5-66314; OH5-68314; OH4-109414; OH4-83912; OH5-48012; OH4-101313; OH4-86812; OH5-60113; OH5-60313; OH5-37311; OH4-86612; OH5-62913; OH4-95813; OH4-90613; OH4-103614; OH5-48212; OH5-48312; OH5-58313; OH5-53513; OH5-63313; OH4-92613; OH5-43812; OH5-56713; OH5-68114; OH4-81412; OH4-98013; OH5-33911; OH5-61913; OH5-52813; OH4-110714; OH5-46312; OH5-51113; OH4-106814; OH4-112714; OH5-63514; OH5-39012; OH5-63013; OH4-111614; OH4-97013; OH4-97613; OH4-107414; OH4-109514; OH4-109614; OH4-92513; OH4-104614; OH4-93113; OH4-85812; OH4-105414; OH4-99913; OH4-91813; OH4-94913; OH4-107914; OH4-83812; OH4-100413; OH4-107214; OH5-41012; OH5-56013; OH4-85612; OH4-99713; OH4-97513; OH5-50312; OH4-109814; OH5-52013; OH5-61413; OH5-61513; OH5-62613; OH5-68614; OH5-51413; OH4-83112; OH4-108114; OH5-68214; OH4-96513; OH5-51513; OH4-100613; OH4-88213; OH5-58813; OH4-91613; OH5-53713; OH5-53813; OH4-98513; OH4-97713; OH5-36411; OH4-106414; OH5-63213; OH5-63413; OH4-100313; OH4-105914; OH5-67214; OH4-81612; OH4-108314; OH5-46612; OH5-46512; OH5-51913; OH4-96713; OH4-103314; OH4-83212; OH4-87012; OH4-95513; OH4-95713;OH5-35611; OH4-86512; OH4-104314; OH4-104414; OH4-110814; OH4-92413; OH4-100013; OH5-54913; OH5-56213; OH4-102414; OH5-39512; OH5-43712; OH4-98713; OH4-98813; OH4-98913; OH5-43912; OH5-39812; OH5-49012; OH5-39112; OH5-48712; OH5-50813; OH5-35811; OH5-55713; OH4-92713; OH5-58213; OH5-50713; OH4-102214; OH4-112614; OH4-96913; OH4-85512; OH4-92213; OH4-100513; OH4-101113; OH4-20446; OH4-20977; OH4-21557; OH4-22207; OH4-22378; OH4-24019; OH4-69311; OH4-70811; OH4-71411; OH143+684-74711; OH4-76212; OH4-76612; OH4-79312; OH4-79912; OH4-81312; OH4-82512; OH4-99213; OH5-20218; OH5-20328; OH5-20558; OH5-20788; OH5-20808; OH5-20818; OH5-20828; OH5-20858; OH5-21108; OH5-21128; OH5-21379; OH5-21679; OH5-22410; OH5-24410; OH5-20618
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and Taiwan.
  • 제품 설명
    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. || Intended for improving the visibility of objects through magnification and illumination.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • 제조사 모회사 (2017)
  • Source
    USFDA