Recall Z-2281-2018— Konica Minolta Medical Imaging USA, Inc.

Name: FDA recall Z-2281-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-09

Class II · Terminated

Class II FDA medical device recall by Konica Minolta Medical Imaging USA, Inc., initiated 2018-05-09, terminated 2020-04-10. It names one FDA 510(k) clearance: K151465. Product: CS-7, Model No. A4C1. 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..

Recalling firm: Konica Minolta Medical Imaging USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Terminated: 2020-04-10
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K151465 — AeroDR SYSTEM 2Konica Minolta, Inc.·cleared 2015-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CS-7, Model No. A4C1

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.