Events

Retiro De Equipo (Recall) de Device Recall IMRIS ORT200 Removable Operating Room 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
    79366
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1217-2018
  • 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=162136
  • 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 rotational locking mechanisms on the ort 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
  • Acción
    The firm disseminated their notices on 02/23/2018 by mail and followed with an email on 02/26/2018. The notice stated: "It has recently come to our attention that the ORT200/300 rotational lock fails to operate such that it cannot change states between locked and unlocked. This may pose a risk of injury to the patient. To minimize the risk of injury, IMRJS is taking the following corrective actions: " ORT200 and 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary. 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 OAT Operator Manuals the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. " During usage, verify the table is locked by manually pushing the table to make sure it does not move rotationally. " If the rotational lock is observed to be not functioning properly, please contact IMRIS Customer Service. The appropriate competent authorities have been notified of this corrective action. IMRIS is committed to patient and user safety, and apologizes for any inconvenience that this may cause. 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 ORT200 Removable Operating Room Table
  • Modelo / Serial
    Serial numbers: 10006997, 10002692, 10006152, 10007192, 10006991, 10002220, 10003754, 10006997, 10004513, 10005201, 10006891, 10004463, 10005189, 10005190, 10004327, 10004997, 10006891
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
  • Descripción del producto
    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • 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