Leica Microsystems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1499-2016)

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.

Class II

An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.

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

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.

Voluntary: Firm initiated