nordicTumorEx 1.0 nordicTumorEx is an image processing recall: Labeling Error
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians…
Why was nordicTumorEx 1.0 nordicTumorEx is an image processing recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 1.0.4
- Product
- nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians…
- Recalling firm
- NordicNeuroLab AS
- Quantity
- 16 licenses
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
- Recall date
- June 6, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)