Events

Retiro De Equipo (Recall) de Device Recall Paper Chart Recorder

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 Gsi Group 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
    72936
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0866-2016
  • Fecha de inicio del evento
    2015-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142532
  • 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
    Recorder, paper chart - Product Code DSF
  • Causa
    The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the prn 50-m+ digital writer.
  • Acción
    On December 2, 2015 GSI Group Corp. distributed Medical Device Correction Notice letter and confirmation forms dated November 18, 2015 to their customers via FedEx. GSI Group Corp. warned customers about a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. Customers are advised to follow all intended usage, cleaning and maintenance instructions that are found in the PRN 50-M+ Digital Writer Technical Manual. It is recommended that customers complete and return the attached Medical Device Correction Confirmation form via email to customerservice@insidesales-solutions.com. GSI Group Corp. will provide a correction at no charge. Once the confirmation form is received, GSI Group Corp. will make arragements to send replacements. Customers with questions can call 781-266-5700.

Device

Device Recall Paper Chart Recorder
  • Modelo / Serial
    Serial Number range: 1801405 through 1918761
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including Puerto Rico; Internationally: Australia, Bahamas, Canada, Germany, Finland, France, Great Britain, Hong Kong, India, Ireland, Italy, Japan, South Korea, Mauritus, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, United Arab Emirates & United Kingdom
  • Descripción del producto
    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 || Product Usage: || The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
  • Manufacturer
    Gsi Group Inc

Manufacturer

Gsi Group Inc
  • Dirección del fabricante
    Gsi Group Inc, 125 Middlesex Tpke, Bedford MA 01730-1409
  • Source
    USFDA