NordicNeuroLab Recalls nordicTumorEx 1.0 Software Due to Image Orientation Errors
NordicNeuroLab AS is recalling 16 licenses of nordicTumorEx 1.0 software because a DICOM header error may cause incorrect image orientation labeling.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect diagnostic interpretation (image flipping), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
NordicNeuroLab AS is recalling 16 licenses of nordicTumorEx 1.0, a medical image processing software package used by trained professionals to analyze dynamic MR imaging datasets of the brain. The software is distributed worldwide, including in the United States, South Africa, Russia, South Korea, the United Kingdom, Japan, Australia, Sweden, Norway, and Greece.
The recall was initiated because an error was discovered in the interpretation of certain DICOM header tags. This error may lead to incorrect orientation labeling, resulting in an indirect left-right, up-down, or anterior-posterior flipping of images. This defect could potentially affect the diagnostic process by presenting anatomical information in an incorrect orientation.
The affected software is version 1.0.4. Users of the software should contact NordicNeuroLab AS for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewin
- Manufacturer
- NordicNeuroLab AS
- Category
- Medical Device — Software
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 1.0.4
Distribution
Distributed nationwide across the United States.
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