Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2050-2018 — nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

U.S. FDA — Device Enforcement · Norway · 2014-09-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2050-2018
Date of alert: 2014-09-17
Country / jurisdiction: Norway
Risk level: Class II
Risk type: recall
Brand: NordicNeuroLab AS
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2050-2018 — nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

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