nordicICE 2 — Class II medical device recall Z-2044-2018
Terminated recall by NordicNeuroLab AS, reported 2018-06-06. An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientat
| Recall number | Z-2044-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, N/A, Norway |
| Recall initiated | 2014-09-12 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2020-10-06 |
| Countries outside the US | AU, CN, DK, ES, FR, GB, IN, JP, KR, MY, NL, NO, PL, RU, SE, SG, SI |
| Quantity | 97 licenses |
| Reason classes | labeling |
Product
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2044-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.