Events

Retiro De Equipo (Recall) de Device Recall ACUSON SC2000

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 Siemens Medical Solutions USA, 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
    71116
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1581-2015
  • Fecha de inicio del evento
    2012-05-11
  • Fecha de publicación del evento
    2015-05-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136153
  • 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 echo, ultrasonic - Product Code IYO
  • Causa
    In some cases, the system is unable to capture a clip or image during a routine scan.
  • Acción
    Siemens sent a Customer Advisory Notice letter to affected customers. The letter identified the affected product. problem and how this issue is being resolved. To resolve this issue on all affected systems, a mandatory software update has been developed and is being installed free of charge.

Device

Device Recall ACUSON SC2000
  • Modelo / Serial
    Model 10433816, software versions VA16C, VA16D and VA16E. Device serial numbers:  400230 400708 400462 400467 400460 400461 400084 451021 400743 400225 450122 400634 400687 400023 400126 400265 400717 400740 400458 400459 400678 400665 450123 400617 400485 400083 400092 451024 400223 400404 450143 400650 400663 400664 400577 400470 400479 400493 400519 400318 400674 400463 400484 400679 400680 400589 400466 400168 400139 400270 400308 400236 400689 400691 450151 400693 400615.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom.
  • Descripción del producto
    ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. || Product Usage: || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA