Z-2044-2018 Class II Terminated
FDA device recall Z-2044-2018 was initiated by NordicNeuroLab AS on September 12, 2014 and is designated Class II. 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 … The recall status is terminated (terminated October 6, 2020). Affected quantity: 97 licenses.
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- September 12, 2014
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97 licenses
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.
Distribution Pattern
Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.
Code Information
Version 2.3.14