Retiro De Equipo (Recall) de Device Recall Konica Minolta CS7 software

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 Konica Minolta Medical Imaging 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
    80220
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2281-2018
  • Fecha de inicio del evento
    2018-05-09
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    Panasonic has issued a mandatory product safety notice, indicating a possibility of battery ignition (fire) in cf-c2 "toughbook" laptops. since konica minolta uses this laptop in some of its product configurations, it notified its customers to utilize a bios utility for the laptops to minimize the risk of an incident while panasonic develops a final solution.
  • Acción
    The firm issued an Important Product Recall Information letter to their affected customers dated May 3, 2018, delivered via UPS Overnight Delivery. The letter notified customers of the Panasonic recall and how it affected the Konica Minolta product. The letter instructed customers to utilize a BIOS Utility for CF-C2 laptops to minimize the risk of an incident while Panasonic develops a final solution. Customers were provided with Technical Bulletin which detailed the steps. Correction Option 1: Update BIOS Environmental Setting using Utility Tool 1. Download the BIOS Utility Tool from the Panasonic Website: ftp://ftp.panasonic.com/ computer/ software/ Panasonic-CF-C2-Charge-Tool.zip 2. Load the Utility Tool onto the CF-C2 Desktop 3. Double-click to run batch file: ChgCtrlUty.bat 4. Optional tool: If Integrated Portable, an external keyboard may be required. Visit KM University at https://km-university.com/ for video instructions: https://km-university.com/course/notification-of-mandatory-safety-bulletin-of-panasonic-toughbook-cf-c2/ Correction Option 2: Manual change to the BIOS Environmental Setting (for Integrated Portable, an external keyboard will be required) 1. If power is on, turn the power off and restart prior to following instructions. 2. Upon boot-up, at Panasonic splash screen, continuously hit the F2 key on the keyboard to access the BIOS. a. Go to the "MAIN" tab associated with the BIOS setting. b. Select "ENVIRONMENT Current Status" setting. c. Ensure "HIGH TEMPERATURE" is selected. Otherwise change this setting to high and click ENTER. d. Go to the "EXlr' tab associated with the BIOS setting. e. Select "SAVE VALUES AND REBOOr' and hit ENTER key on the keyboard. f. A prompt will appear to state, "SAVE VALUES". Select YES and hit ENTER. If you have any questions, need a keyboard, require assistance with these instructions, and/or a safety verification please contact our Customer Care Team at (800) 945-045

Device

  • Modelo / Serial
    All version numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.
  • Descripción del producto
    CS-7, Model No. A4C1
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Konica Minolta Medical Imaging USA, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
  • Source
    USFDA