The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2042-2018·Announced 2018-06-06

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.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer
NordicNeuroLab AS
Category
Medical Device — Software
Hazard
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.

Related recalls

Same manufacturer · NordicNeuroLab AS

See all →

Same hazard · mis labeling

See all →

Similar recalls