Retiro De Equipo (Recall) de Device Recall Stryker SHAPE ARM, SINGLE

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 Stryker Communications.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    medical equipment support boom - Product Code BRY
  • Causa
    During the use of the shape arm there is the potential for the monitor mount to come off of the shape arm if the lock washer and screw are not present.
  • Acción
    Direct accounts in the US were notified by letter dated March 21, 2014, and asked to report any malfunctions to Stryker Communications immediately. In addition, Stryker Representatives will visit all US accounts to inspect all the product units on hand. If needed, Representatives will check that black, screw/lock washers supplied by Stryker are secured in place and will replace any that are not the typed furnished by Stryker. All units will be updated with a yellow, warning sticker on the monitor bracket which reads: "Failure to properly install the screw and lock washer below can result in the attached component/equipment falling." Stryker Communications' foreign distributors will oversee notification, inspection, and corrections of their accounts and report corrections and other findings to Stryker Communications.


  • Modelo / Serial
    Serial numbers 111018DE001 through 140210DE020  Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
  • Descripción del producto
    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
  • Manufacturer


  • Dirección del fabricante
    Stryker Communications, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Empresa matriz del fabricante (2017)
  • Source