FDA Device recall Z-2044-2018
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians by Nordicneurolab As, citing 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-p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2044-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-12 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nordicneurolab As |
| Distribution | n/a |
Product
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Reason
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.
Identifiers
| code_info | Version 2.3.14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2044-2018%22
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