Events

Retiro De Equipo (Recall) de Device Recall T3 (Trumpf Table Top) 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 Allen Medical Systems.

¿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
    79613
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1262-2018
  • Fecha de inicio del evento
    2018-02-21
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162773
  • 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
    unknown device name - Product Code N/A
  • Causa
    The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
  • Acción
    On February 2, 2018, the firm issued an Urgent Medical Device Correction notification to their distributors to make them aware of the device correction. The firm requested that distributors further disseminate an attached recall letter to consignees. The communication addressed to consignees advised of the issue affecting the device. Consignees were asked to inform users that the device is for armboard use only, and not to be used with the product system's leg support. The notice informed consignees that the firm would provide new units upon completion of development along with revised Instructions for Use. Customers with questions concerning this Urgent Medical Device Correction were referred to Allen Medical Customer Service: (800) 433-5774, 8:30AM-5PM (EST)

Device

Device Recall T3 (Trumpf Table Top) System
  • Modelo / Serial
    Serial Numbers:  A166677 A201568 A311424 A333604 A353171 A385408 A166678 A201569 A311425 A339446 A357145 A385409 A170724 A201570 A314187 A339447 A359864 A385410 A179337 A209110 A319402 A348001 A362219 A386775 A182027 A209111 A320583 A348174 A364982 A386776 A183578 A209112 A320584 A348175 A369558 A386777 A188535 A209113 A322480 A348176 A369884 A386778 A194789 A282259 A322597 A348177 A370262 A390698 A194790 A282260 A325663 A348178 A372387 A390699 A197337 A282537 A325664 A348179 A378593 A390700 A197338 A282538 A326358 A352174 A378594 A390701 A197339 A309460 A331161 A352175 A378595 A390702 A197554 A309461 A331162 A352176 A378596 A390703 A198334 A309462 A331163 A352177 A378597 A395121 A198335 A309463 A333601 A353168 A384029 A395122 A198336 A309464 A333602 A353169 A384329 A395123 A201567 A309465 A333603 A353170 A384330
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.
  • Descripción del producto
    F-T3SYSTEM, T3 (Trumpf Table Top) System || The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
  • Manufacturer
    Allen Medical Systems

Manufacturer

Allen Medical Systems
  • Dirección del fabricante
    Allen Medical Systems, 100 Discovery Way, Acton MA 01720-4481
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA