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Recall Observatory FDA recall evidence

Device product

nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

Z-2044-2018

September 12, 2014

Class II

Product summary

Firm
NordicNeuroLab AS
Event
Event 78463
Status
Terminated
Classification
Class II
Quantity
97 licenses
Official record key
device-enforcement:Z-2044-2018

Official wording

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.

Code information: Version 2.3.14

Distribution pattern: Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.