nordicICE 2.3.14 Image processing software package used recall: Labeling Error
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Why was nordicICE 2.3.14 Image processing software package used 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 2.3.14
- Product
- nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
- Recalling firm
- NordicNeuroLab AS
- Quantity
- 97 licenses
- Distribution
- Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.
- Recall date
- June 6, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)