Events

Retiro De Equipo (Recall) de Device Recall Compensator Slider Lambda 6x20 component

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 Zeiss, Carl 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
    Recall
  • ID del evento
    67178
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0799-2014
  • Fecha de inicio del evento
    2013-12-20
  • Fecha de publicación del evento
    2014-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124877
  • 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
    Light, microscope - Product Code IBJ
  • Causa
    Carl zeiss microscopy, llc has recalled the compensator slider lamda 6x20 component utilized on standard pathology microscopes due to misalignment of the lambda plate.
  • Acción
    Carl Zeiss, Inc. sent an Important Medical Device Corrective Action letter dated December 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that their service provider would contact them to schedule a visit in which a factory trained service technician would install a new Compensator Slider Lambida 6x20. Customers should return the old Compensator Slider to the factory for testing. Customers with technical questions were instructed to call 914-681-7815.

Device

Device Recall Compensator Slider Lambda 6x20 component
  • Modelo / Serial
    part number 473704-0000-000
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
  • Descripción del producto
    Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). || Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
  • Manufacturer
    Zeiss, Carl Inc

Manufacturer

Zeiss, Carl Inc
  • Dirección del fabricante
    Zeiss, Carl Inc, 1 Zeiss Dr, Thornwood NY 10594-1939
  • Empresa matriz del fabricante (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA