FDA Medical Device Recalls (openFDA)
Konica Minolta Medical Imaging USA, Inc.: ImagePilot, Model No. D9MA
- Recall number
- Z-2282-2018
- Recalling firm
- Konica Minolta Medical Imaging USA, Inc.
- Product
- ImagePilot, Model No. D9MA
- Status
- Terminated
- Initiated
- 2018-05-09
- Posted
- not on file
- Terminated
- 2020-04-10
- 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.
- Root cause
- Unknown/Undetermined by firm
- 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
- Quantity
- not on file
- Distribution
- Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.
- Lot, serial or model codes
- All version numbers.
- 510(k) numbers
- ["K071436"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28