Company:AGFA Healthcare Corp.
Date of Enforcement Report 7/26/2017
Class lI:
PRODUCT
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Recall Number Z-2735-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
AGFA Healthcare Corp., Greenville, SC on 12/21/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
221 units
DISTRIBUTION
Nationwide Distribution.
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