nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Reported: June 6, 2018 Initiated: September 12, 2014 #Z-2044-2018
Product Description
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.
Details
- Recalling Firm
- NordicNeuroLab AS
- Units Affected
- 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.
- Location
- Bergen, N/A
Frequently Asked Questions
What product was recalled? ▼
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.. Recalled by NordicNeuroLab AS. Units affected: 97 licenses.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-2044-2018.
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