Events

Retiro De Equipo (Recall) de Device Recall InMotion Hand a.k.a. InMotion 5.0

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 Interactive Motion Technologies, 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
    72326
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0199-2016
  • Fecha de inicio del evento
    2012-05-05
  • Fecha de publicación del evento
    2015-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141071
  • 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
    System, isokinetic testing and evaluation - Product Code IKK
  • Causa
    Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
  • Acción
    Interactive Motion Technology ( IMT) sent an Important Patient Safety Information letter dated March 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Summary of Actions to be taken For Hand Robot Cover B, firm recommends continued vigilance for both Adult and Pediatric Patients while in contact with this group of devices. For Hand Robot Covers A or C, at clinician discretion based on expected patient population, firm recommends continued use when appropriate of the IMT supplied Hypertonia Spring Assembly, or if not appropriate, insertion of the IMT Zero Force Spring Assembly. IMT will make this kit available for each Hand Robot upon request, or insert the Assembly when the Hand Robot is shipped to IMT using the special shipping container. If you have any questions, please contact your local IMT Representative or IMT Technical Services at support@interactive-motion.com.

Device

Device Recall InMotion Hand a.k.a. InMotion 5.0
  • Modelo / Serial
    Serial Numbers: H006, H007, H019, H020, H021, H022, H023, H024. Note: serial numbers may be written with an additional leading 0 (e.g. H0024 instead of H024)
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : Texas and Tennessee., and to the countries of : China, Brazil, Hong Kong, Austria and South Korea.
  • Descripción del producto
    Robotic hand accessory to InMotion Arm, rehabilitation robot.
  • Manufacturer
    Interactive Motion Technologies, Inc.

Manufacturer

Interactive Motion Technologies, Inc.
  • Dirección del fabricante
    Interactive Motion Technologies, Inc., 80 Coolidge Hill Rd, Watertown MA 02472-5003
  • Empresa matriz del fabricante (2017)
    Bionik Laboratories Inc
  • Source
    USFDA