FDA recall Z-2044-2018

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.

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.

Key facts

Status

Terminated

Initiation date

2014-09-12

Report date

2018-06-06

Termination date

2020-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bergen, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2044-2018