BEUDAMED
    FDA Recall Terminated

    ImagePilot, Model No. D9MA

    Recall: Z-2282-2018 · Initiated May 9, 2018

    Recall

    Recall Number
    Z-2282-2018
    Event Number
    80220
    Firm
    Konica Minolta Medical Imaging USA, Inc.
    FEI Number
    2241281
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    May 9, 2018
    Terminated
    April 10, 2020
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    ImagePilot, Model No. D9MA

    Reason

    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.

    Action

    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

    Distribution

    Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.