Agfa Healthcare NX 3.0.8950 Software Cl II

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.

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.