Events

Retiro De Equipo (Recall) de Device Recall IMRIS T2X Table

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 Deerfield Imaging, 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
    79488
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1265-2018
  • Fecha de inicio del evento
    2018-02-23
  • 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=162457
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Causa
    The operating room table may drift while in use, which could potentially result in unintended movement of the table.
  • Acción
    The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush and filter change will be performed. " ORT300 tables: all customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed.A drift test will also be performed. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS. IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the ORT Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies. Before each surgery, inspect the table for any visibly loose components or hydraulic fluid leaks and check that the headrest and tabletop safety latches are secured. .Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@imris.com if you have any questions or concerns."

Device

Device Recall IMRIS T2X Table
  • Modelo / Serial
    (a) 108000-000, Serial Numbers: 10000239, 10000983, 10000233 (b) 108000-600, Serial Numbers: 10001306 (c) 109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d) 109682-600, Serial Numbers: 10001119, 10003623, 05-002, 10003634, 10001188, 10003638, 10001192
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, China, Australia, Sweden, Germany
  • Descripción del producto
    IMRIS T2X Table, Part Numbers: || (a) 108000-000 || (b) 108000-600 || (c) 109682-000 || (d) 109682-600
  • Manufacturer
    Deerfield Imaging, Inc.

Manufacturer

Deerfield Imaging, Inc.
  • Dirección del fabricante
    Deerfield Imaging, Inc., 5101 Shady Oak Rd S, Minnetonka MN 55343-4100
  • Empresa matriz del fabricante (2017)
    Deerfield Management Company L.P.
  • Source
    USFDA