Z-2282-2018Class II

ImagePilot, Model No. D9MA

Name: Z-2282-2018 ImagePilot, Model No. D9MA
Creator: Konica Minolta Medical Imaging USA, Inc.
Published: 2018-05-09
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2018-05-09 / Terminated

FDA source

Konica Minolta Medical Imaging USA, Inc. began a recall of ImagePilot, Model No. D9MA on 2018-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2282-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Posted: 2018-06-22
Terminated: 2020-04-10
Recalling firm: Konica Minolta, Inc.
Product: ImagePilot, Model No. D9MA
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
FDA 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
Distribution: Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.
Product codes and lots: All version numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2282-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2281-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2282-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22

Product code LLZ

K071436Class IIRegius UniteaKonica Minolta Medical & Graphic, Inc. / cleared 2007-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)