Retiro De Equipo (Recall) de Device Recall Leica Microsystems (Schweiz) AG,

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Leica Microsystems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Microscope, surgical, general & plastic surgery - Product Code FSO
  • Causa
    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.
  • Acción
    The URGENT MEDICAL DEVICE RECALL letter was sent via USPS mail and email on January 25th 2016 to consignees describing the reason for the recall and the necessary steps to take. These included the following: Continue to use the system according to the User Manual. Both illumination units should be checked prior to beginning any operation case. The Leica M525 OH4 and Leica M720 OH5 provide two redundant illumination units. Independent from the issue explained, the user should be reminded that if they notice a failure in the illumination unit that they are currently using, they should switch to the back-up illumination at the next opportunity during surgery by using the "Change Lamp" page 37 for M525 OH4 and page 40 for M720 OH5 button on the control unit "Main" screen (see Picture 2 below) as described in user manual. Changing lamps will interrupt the illumination for less than 5 seconds. They should contact their Leica Microsystems representative for repair of the defective illumination unit before using the instrument for the next surgery. Note: The user manuals of the Leica M525 OH4 and Leica M720 OH5 state: ¿ Never begin an operation with only one functioning xenon lamp! ¿ Like any other instrument in the operating theater this system may fail. Leica Microsystems therefore recommends that a backup system be kept ready during the operation. The recall further describes transmission of the field notice: The notice must be passed on to all those within their organization who need to be aware of it and to any organization where the affected devices has been sold, rented, leased or otherwise transferred. The end users are requested to confirm receipt of the notice by signing, dating and returning the attached Acknowledgement Form' with the serial number of their instrument back to Leica Microsystems by email to: within 10 working days after receipt of field safety notice.


  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    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.
  • Descripción del producto
    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


  • Dirección del fabricante
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Empresa matriz del fabricante (2017)
  • Source