Device recall: CS-7, Model No. A4C1

Class II FDA enforcement event 80220. Recall start date: 9 May 2018. Status in the FDA record: Terminated. Termination date: 10 Apr 2020.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Konica Minolta Medical Imaging USA, Inc. started this device recall on 9 May 2018. The firm address in the FDA record is in Wayne, NJ. FDA put the recall in Class II. FDA event 80220 has 2 product records. The first FDA enforcement report date is 4 Jul 2018. The record gives the status Terminated, with the termination date 10 Apr 2020.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Konica Minolta Medical Imaging USA, Inc., Wayne, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 80220: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2281-2018	CS-7, Model No. A4C1		Class II	Terminated	4 Jul 2018
Z-2282-2018	ImagePilot, Model No. D9MA		Class II	Terminated	4 Jul 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 2Median of the firm: 4
Events of the firm on the register: 2

Other events of the firm

Other FDA enforcement events of Konica Minolta Medical Imaging USA, Inc.
Initiated	Product (first record)	Type	Class	Records
4 Dec 2017	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031	Device	Class II	4

Official channels

FDA enforcement report Z-2281-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 80220. https://recallregister.com/fda/ii/80220/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.
How many FDA recalls does Konica Minolta Medical Imaging USA, Inc. have?: Konica Minolta Medical Imaging USA, Inc. is the recalling firm in 2 enforcement events on this register. This event is 1 of them.