ClearanceBrief
Recall Z-2281-2018 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Konica Minolta Medical Imaging USA, Inc.

CS-7, Model No. A4C1

DateMay 9, 2018
StatusTerminated
ReasonPanasonic 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 causeUnknown/Undetermined by firm
ActionThe 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 Pa
DistributionNationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K151465AeroDR SYSTEM 2
Konica Minolta, Inc., Jun 29, 2015