Retiro De Equipo (Recall) de Device Recall Penner Patient Transfer/Lift System

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 Penner Mfg 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Lift, patient, ac-powered - Product Code FNG
  • Causa
    Incomplete weld on the pillar mounting bracket.
  • Acción
    The firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax to 402 694-5844 or mail to Penner Manufacturing Inc, 102 Grant Street, Aurora, NE 68818, Attn: Quality Assurance Manager. Penner stated in the letter, if welds are not complete (no weld), discontinue use and contact the Quality Assurance Manager at Penner Manufacturing immediately at 402-694-5003. If you have any questions, contact the Quality Assurance Manager at 402-694-5003.


  • Modelo / Serial
    Serial number 11030504601, 11040711001, 02060991001,  02060998801, and 02060998802
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and countries including: Canada and Mexico.
  • Descripción del producto
    Penner Manufacturing Transfer Electric Superior left entry with scale, Patient Transfer/Lift System, Models 388000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. || For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
  • Manufacturer


  • Dirección del fabricante
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source