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AGFA Healthcare Corp. recalls Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Recalled July 26, 2017 · FDA recall Z-2735-2017 · AGFA Healthcare
Hazard
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. · FDA Class II
Units
221 units
Sold at
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
Description
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.
Product
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Manufacturer(s)
AGFA Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →