Events

Retiro De Equipo (Recall) de Device Recall Karma

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 Karman Healthcare 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
    73159
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1025-2016
  • Fecha de inicio del evento
    2016-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143292
  • 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
    Wheelchair, mechanical - Product Code IOR
  • Causa
    Karman healthcare, inc. is recalling karma flexx wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
  • Acción
    On 01/27/16 the firm sent out customer notification letters. In the letter customers were informed that the firm was conducting a product update for original purchasers of KM8522. Customers were provided the following procedures for the product update: 1. Completed and signed notification must be returned to Karman Healthcare via fax at (626)-581-2335, or e-mail to edward@karmanhealthcare.com. 2. Following the received frame, customers may install their current wheels, and footrest onto the newly updated frame. Kindly package the used frame into the carton in the same manner the new carton was shipped. 3. A prepaid return shipping label is included with the letter, which customers may use to return the carton; or contact the firm's customer service line at (800)-805-2762 to have a trained representative schedule a pickup at no charge.

Device

Device Recall Karma
  • Modelo / Serial
    Item #  935-0245H6 Flexx (KM852216) Serial #  TM14-A03982-TM14-A03991  Item # 935-0246H6 Flexx (KM852218) Serial #  TM14-A03992-TM14-A04012  Item # 935-0247H6 Flexx (KM852220) Serial #  TM14-A4013-TM14-A04017
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following states -- WA, CA, NY, and TX.
  • Descripción del producto
    Karma Flexx Wheelchair || Manual Wheelchair.
  • Manufacturer
    Karman Healthcare Inc

Manufacturer

Karman Healthcare Inc
  • Dirección del fabricante
    Karman Healthcare Inc, 19255 San Jose Ave, City of Industry CA 91748-1418
  • Empresa matriz del fabricante (2017)
    Karman Healthcare Inc
  • Source
    USFDA