26
Jul
2017

Agfa Healthcare NX 3.0.8950 Software Cl II

0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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