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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 026 08 18 000
Date submitted: 8/7/2018
Manufacturer:AGFA Corp.
Device Type:Enterprise Imaging for Radiology.
Medical Device Identifier:-Enterprise Imaging for Radiology 8.0.0, 8.0.0 SP1 & 8.0.0 SP2.

-Enterprise Imaging for Radiology 8.0.1, 8.0.1 SP1, 8.0.1 SP2, 8.0.1 SP3, 8.0.1 SP4, 8.0.1 SP5 & 8.0.1 SP6.

-Enterprise Imaging for Radiology 8.1, 8.1 SP1 & 8.1 SP2.
Reason of Field Safety Corrective Action: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.
Remedy Action:1. The issue and solution related to the problem has also been communicated via Knowledge Article KA0014395 which has been published externally and can be viewed on the Customer Service Web (https://my.agfahealthcare.com/).

2. The permanent solution for this issue has been released in:

-Enterprise Imaging 8.0.1 SP7 on December 15, 2016.

-Enterprise Imaging 8.1.1 on August 18, 2017.

An Agfa HealthCare service representative will contact you to arrange for a date to deploy the appropriate upgrade at your facility.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:AC2C0B701816B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: AGFA Corp.pdf