Recall – PACS Software Error

Company: Agfa Healthcare NV
Date of Enforcement Report 10/17/2018
Class II:

PRODUCT
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS

Recall Number: Z-0101-2019

REASON
Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top.

RECALLING FIRM/MANUFACTURER
Agfa Healthcare NV, Mortsel, Belgium on 8/3/2018

Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
17

DISTRIBUTION
US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.

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

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.