Events

Retiro De Equipo (Recall) de WARMAIR HYPERTHERMIA UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CINCINNATI SUB-ZERO PRODUCTS.

¿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
    148313
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-08-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    In 2009 fda cited cincinnati sub-zero products inc. (csz) for not obtaining proper clearance for the warmair model 135 device fda did not accept csz's rationale for not requiring 510(k) clearance on the device. as a corrective action csz submitted an application for clearance. in october 2010 csz received 510(k) clearance of the warmair 135 device. during the review process however csz made changes to the warmair 135 manual. prior to receiving 510(k) clearance the device was also certified to iec 60601-1-2 which required additional changes to the manual (which were included with the 510(k) submission).

Device

WARMAIR HYPERTHERMIA UNIT
  • Modelo / Serial
    Model Catalog: 135 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    WARMAIR MODEL 135
  • Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS

Manufacturer

CINCINNATI SUB-ZERO PRODUCTS
  • Dirección del fabricante
    CINCINNATI
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    HC