Events

Retiro De Equipo (Recall) de Device Recall CareVue Chart

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 Philips Healthcare 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
    51982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1436-2009
  • Fecha de inicio del evento
    2009-05-05
  • Fecha de publicación del evento
    2009-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81825
  • 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 Cathode-Ray Tube Display - Product Code DXJ
  • Causa
    Software: a software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period.
  • Acción
    Philips Medical notified accounts by letter on 5/6/09 the Urgent - Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within CareVue Chart to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist. Philips is currently developing a correction that will be available at no additional charge. A Philips representative will notify customers when the software correction becomes available. If further assistance is needed, customers are to contact the Philips Customer Care Center at 1-800-722-9377.

Device

Device Recall CareVue Chart
  • Modelo / Serial
    Serial Numbers: 4621A00101, 4621A00102, 4621A00103, 4621A00104, 4621A00105, 4621A00106, 4621A00107, 4621A00108, 4621A00109, 4621A00110, 4621A00111, 4621A00112, 4621A00113, 4621A00114, 4621A00115, 4621A00116, 4621A00117, 4621A00118, 4621A00119, 4621A00120, 4621A00121, 4621A00122, 4621A00123, 4621A00124, 4621A00125, 4621A00126, 4621A00127, 4621A00128, 4621A00129, 4621A00130, 4621A00131, 4621A00132, 4621A00133, 4621A00134, 4621A00135, 4621A00136, 4621A00137, 4621A00138, 4621A00139, 4621A00140, 4621A00141, 4621A00142, 4621A00143, 4621A00144, 4621A00145, 4621A00146, 4621A00147, 4621A00148, 4621A00149, 4621A00150, 4621A00151, 4621A00152, 4621A00153, 4621A00154, 4621A00155, 4621A00156, 4621A00157, 4621A00158, 4621A00159, 4621A00160, 4621A00161, 4621A00162, 4621A00163, 4621A00164, 4621A00165, 4621A00166, 4621A00167, 4621A00168, 4621A00169, 4621A00170, 4621A00171, 4621A00172, 4621A00193, 4621A00194, 4621A00195, 4621A00196, 4621A00197, 4621A00198, 4621A00199, 4621A00200, 4621A00201, 4621A00202, 4621A00203, 4621A00204, 4621A00205, 4621A00206, 4621A00207, 4621A00208, 4621A00209, 4621A00210, 4621A00211, 4621A00213, 4621A00214, 4621A00217, 4621A00218, 4621A00219, 4621A00220, 4621A00221, 4621A00222, 4621A00223, and  4621A00224.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of CA, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom.
  • Descripción del producto
    CareVue Chart Release C.O || Part Number: 862246 || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA