Events

Retiro De Equipo (Recall) de Device Recall Elite 2

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 Natus Neurology 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
    77569
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2726-2017
  • Fecha de inicio del evento
    2017-06-09
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156547
  • 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
    Monitor, ultrasonic, nonfetal - Product Code JAF
  • Causa
    Some of the elite 2 and 3 obstetric probes and 5 mhz vascular probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
  • Acción
    Customer notification via an Urgent Recall Notification/Field Notice began 06/09/2017. The letter identified the affected product and the reason for the recall. Customers were asked to complete and return the attached verification form. The firm will replace functioning probes that returned free of charge. Customers are to follow the instructions provided for returning any affected devices.

Device

Device Recall Elite 2
  • Modelo / Serial
    Serial numbers: CER0179 CER0240 CER0241 CER0242 CER0243 CER0244 CER0245 CER0246 CER0247 CER0248 CER0249 CER0250 CER0251 CER0252 CER0253 CER0254 CER0255 CER0256 CER0257 CER0258 CER0259 CER0260 CER0261 CER0262 CER0263 CER0264 CER0265 CER0266 CER0267 CER0268 CER0269 CER0270 CER0271 CER0272 CER0273 CER0274 CER0275 CER0276 CER0277 CER0278 CER0279 CER0280 CER0281 CER0282 CER0283 CER0284 CER0285 CER0286 CER0287 CER0288 CER0289 CER0290 CER0291 CER0292 CER0293 CER0294 CER0295 CER0296 CER0297 CER0298 CER0299 CER0300 CER0301 CER0302 CER0303 CER0304 CER0305 CER0306 CER0307 CER0308 CER0309 CER0310 CER0311 CER0312 CER0313 CER0314 CER0315 CER0316 CER0317 CER0318 CER0319 CER0320, and CER0321.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and, to the countries of Australia, Canada, Chile, Columbia, Germany, India, Japan, Jordan, Kuwait, Netherlands, Papua Guinea, Philippines, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, and United Kingdom.
  • Descripción del producto
    Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. || Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
  • Manufacturer
    Natus Neurology Inc

Manufacturer

Natus Neurology Inc
  • Dirección del fabricante
    Natus Neurology Inc, 3150 Pleasant View Rd, Middleton WI 53562-4800
  • Empresa matriz del fabricante (2017)
    Natus Medical Incorporated
  • Source
    USFDA