Events

Retiro De Equipo (Recall) de Device Recall Actiwatch 64 AM,

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 Mini-Mitter Company, 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
    38368
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0326-2008
  • Fecha de inicio del evento
    2007-06-27
  • Fecha de publicación del evento
    2008-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65464
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    Patient Physiological Monitor - Product Code M HX
  • Causa
    Communication failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. if left unaddressed, the issues can lead to permanent communication failure.
  • Acción
    A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.

Device

Device Recall Actiwatch 64 AM,
  • Modelo / Serial
    Serial Numbers: V960132, V960133, V960135, V960191, V960253, V960254, V960255, V960256, V960257, V960314, V960460, V960461, V960469, V960481, V960483, V960487, V960488, V960504, V960505, and V960550
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide
  • Descripción del producto
    Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon
  • Manufacturer
    Mini-Mitter Company, Inc.

Manufacturer

Mini-Mitter Company, Inc.
  • Dirección del fabricante
    Mini-Mitter Company, Inc., 20300 Empire Ave Ste B3, Bend OR 97701
  • Empresa matriz del fabricante (2017)
    Mini Mitter Co Inc
  • Source
    USFDA