Events

Retiro De Equipo (Recall) de Centricity PACS Workstation

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 GE Healthcare.

¿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
    68092
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1665-2014
  • Fecha de inicio del evento
    2014-04-03
  • Fecha de publicación del evento
    2014-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126929
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the centricity pacs ra1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. the issue can occur with a previously displayed study that remains open in the background. if one or more, but not all, images in.
  • Acción
    An URGENT MEDICAL DEVICE CORRECTION letter dated April 3, 2014 was sent to all direct accounts. The letter included instruction to customers to use until the permanent fix for this issue is deployed: 1) Check to see if the DelRejImg task is active and running. a) Log into CA Tool. b) From the Navigation menu, select System Monitor. c) From the pull down menu, select Dbase Maintenance. d) Scroll to the DelRejImg task (this list is alphabetical). e) Review the Task Status. Possible statuses are IDLE or SUSPEND f) If the task status is set to SUSPEND The task is not running. g) If the task is set to IDLE, move to Step 2. 2) Check the Minimum Rejected Image Deletion Time. a) From the Navigation menu, select Sys. Configuration. b) From the pull down menu, select PACS Configuration. c) Scroll to Minimum Rejected Image Deletion Time (this list is alphabetical). d) Review the Value field. e) If the value field is a negative integer (such as the default setting of -1), the Delete Rejected Image process is NOT running and there is no patient safety hazard. If the value field is a positive integer (such as 1 or higher), the Delete Rejected Image process IS running and there is a potential patient safety hazard. 3) A GE Healthcare Service Representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will prevent the DelRejImg task from running, and prevent any rejected images from being deleted. This feature is being removed entirely from the 3.2 release family of Centricity PACS and will be reinstated in a future 4.X workstation release of Centricity PACS. 4) Perform the reject image workflow with only one patient study open at a time. A future release of Centricity PACS will address the unintentional rejected image issue. Until a correction for the unintentional rejected image issue is available, a GE Healthcare service representative will remove the DelRejImg task table in the Centricity PACS database. This will remove the re

Device

Centricity PACS Workstation
  • Modelo / Serial
    Centricity PACS versions: 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 3.2 SP8; 4.0; 4.0.1; 4.0 SP3
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV, and the countries of Australia, Canada, Chile, France, Germany, India, Ireland, Israel, Italy, Japan, Korea (South), Kuwait, Lebanon, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA