Retiro De Equipo (Recall) de P-600 PORTABLE CEILING LIFT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PRISM MEDICAL USA.

¿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
    65840
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-15
  • País del evento
  • 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
    Prism medical ltd. has found that the c-series& p600 lift strap for lifts manufactured between april 25 2017 and june 12 2017 may wear prematurely at max load (625 lbs). they have identified the root cause as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.

Device

  • Modelo / Serial
    Model Catalog: 303090 (Lot serial: PH603851); Model Catalog: 303090 (Lot serial: PH603850); Model Catalog: 303093 (Lot serial: PH603850); Model Catalog: 303090 (Lot serial: PH603852); Model Catalog: 303093 (Lot serial: PH603852); Model Catalog: 303093 (Lot serial: PH603851); Model Catalog: 323100 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 323917 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 323117 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 323417 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 323846 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    P-600 CEILING LIFT;C-450 CEILING LIFT;C625 CEILING LIFT
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MARYLAND HEIGHTS
  • Empresa matriz del fabricante (2017)
  • Source
    HC