Events

Retiro De Equipo (Recall) de Device Recall Viasys Healthcare, Sonora Transcranial Doppler (TCD) System

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 Cardinal Health, 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
    50875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0998-2009
  • Fecha de inicio del evento
    2009-01-06
  • Fecha de publicación del evento
    2009-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77578
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    Internal testing has identified several several scenarios where unexpected system lockups, shutdowns or system errors would render the sonara unavailable for use until the sonara can be restarted. these issues can be corrected by installing the version 6.0 b045 software updating the audio driver and updating to xp service pack 3. additionally, improper wiring could cause the cooling fan to not op.
  • Acción
    Consignees were sent a Cardinal Health "Urgent: Medical Device Correction" letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. The letter was addressed to customers describing the problems and systems affected and solutions. Cardinal Health requested customers to complete the actions listed in the letter to install the Field Correction and return the completed "Verification Form" via mail, e-mail or fax to Cardinal Health-NeuroCare. Further information can be obtained by calling 1-800-356-0007 ext 2191 or fax to 1-877-244-3805.

Device

Device Recall Viasys Healthcare, Sonora Transcranial Doppler (TCD) System
  • Modelo / Serial
    Serial Numbers:  PWH0297 PWH0212 PWH0221 PWH0309 PWH0246 PWH0250 PWH0223 PWH0429 PWH0245 PWH0292 PWH0298 PWH0214 PWH0211 PWH0210 PWH0219 PWH0216 PWH0224 PWH0215 PWH0213 PWH0220 PWH0253 PWH0252 PWH0254 PWH0221 PWH0218 PWH0217 06-2506 06-2504 05-2506 PWH0251 06-2501 06-2500 06-2503 06-2502 05-2502 and 05-2500.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including THAILAND, SINGAPORE, SERBIA-MONTENEGRO, PORTUGAL, PHILIPPINES, POLAND, NORWAY, NETHERLANDS, KOREA, ITALY, ISRAEL, HUNGARY, HONG KONG, GREAT BRITAIN, SPAIN, GERMANY, CZECH REPUBLIC, SWITZERLAND, CANADA, BULGARIA, and BOSNIA-HERZEGOVINA.
  • Descripción del producto
    Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. || The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins.
  • Manufacturer
    Cardinal Health, Inc

Manufacturer

Cardinal Health, Inc
  • Dirección del fabricante
    Cardinal Health, Inc, 5225 Verona Rd, Madison WI 53711-4497
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA