FDA-Device2017-07-26Class II
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
AGFA Healthcare Corp.
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.
Sold states
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
Affected count
221 units
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2735-2017Don't want to check this manually?
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