FDA recall Z-2282-2018

Konica Minolta Medical Imaging USA, Inc. · Class II · device

Product

ImagePilot, Model No. D9MA

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-05-09
Report date
2018-07-04
Termination date
2020-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2282-2018