Events

Retiro De Equipo (Recall) de Device Recall Pentax Rigid Laryngostroboscopes

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 Pentax of America 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
    76089
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1075-2017
  • Fecha de inicio del evento
    2016-12-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152137
  • 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
    Laryngostroboscope - Product Code EQL
  • Causa
    Pentax is initiating a field correction to revise the instructions for use of the rigid laryngostroboscopes model 9106 and 9108.
  • Acción
    The firm, Pentax Medical, sent an "U.S. URGENT FIELD CORRECTION" letter and a Return Response form dated December 12, 2016 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all users read and carefully follow the revised IFU in order to properly operate and reprocess the affected product; contact your PENTAX Medical sales representative to arrange for training regarding the new procedures, and complete and return the FIELD CORRECTION RESPONSE FORM via fax to: PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or email a pdf copy to customeradvisories@pentaxmedical.com even if you no longer possess the product. If you have any questions regarding this action, please feel free to contact us at: 800-431-5880 (8:30 AM-5:00 PM, Monday-Friday, EST) or email: customeradvisories@pentaxmedical.com.

Device

Device Recall Pentax Rigid Laryngostroboscopes
  • Modelo / Serial
    Model #'s 9106 and 9108
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
  • Manufacturer
    Pentax of America Inc

Manufacturer

Pentax of America Inc
  • Dirección del fabricante
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA