Reported Jun 6, 2018 · Terminated
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical…
NordicNeuroLab AS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NordicNeuroLab AS · Mollendalsveien 65c · Bergen, N/A · N/A
Is this the product you have?
- nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
- Lot codes and dates
- Version 2.3.14
- Amount recalled
- 97 licenses
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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