AGFA Healthcare Corp. recalls Agfa Healthcare NX 3.0.8950 Imaging Processing Software

Recall date

December 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2735-2017

FDA classification

Class II

Brand / firm

AGFA Healthcare Corp.

Sold / distributed

AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada

Why it was recalled

A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Agfa Healthcare NX 3.0.8950 Imaging Processing Software