Cl II nordicICE 2.3.14 image processing software

Company:NordicNeuroLab AS
Date of Enforcement Report 6/6/2018
Class lI:

PRODUCT

nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Recall Number: Z-2044-2018

REASON
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

RECALLING FIRM/MANUFACTURER
NordicNeuroLab AS, Bergen Norway on 9/12/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
97 licenses

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Tampa, FL 33624
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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.