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U.S. Department of Health and Human Services

Class 2 Device Recall Enterprise Imaging Desktops

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  Class 2 Device Recall Enterprise Imaging Desktops see related information
Date Initiated by Firm August 03, 2018
Create Date October 11, 2018
Recall Status1 Terminated 3 on April 03, 2020
Recall Number Z-0101-2019
Recall Event ID 80998
510(K)Number K111945  
Product Classification System, image processing, radiological - Product Code LLZ
Product Enterprise Imaging Desktops

Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Code Information Versions 8.0.0, 8.0.0 SP1 & 8.0.0 SP2., 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., 8.1, 8.1 SP1, 8.1 SP2.
Recalling Firm/
Manufacturer		 Agfa Healthcare NV
Septestraat 27
Mortsel Belgium
For Additional Information Contact Cassandra McGowan
864-421-1984
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action The firm, Agfa, sent an "URGENT FIELD SAFETY NOTICE Medical Device Recall" Notice dated 8/3/18 to its customers. The notification described the product, problem and actions to be taken. The notification letters instructed customers to do the following: 1. Please instruct your users to pay extra attention when selecting a study in the Clinical Side Bar to be sure they are reporting on the active study and not on one of the comparison studies. The active and comparison study are clearly differentiated from each other via blue (active) and grey (comparison) icons in both the Text and Image Area. The images show the date the study was performed. 2. We recommend that an upgrade be applied to correct this issue. Refer to the table for affected versions and associated correction. An Agfa HealthCare service representative will contact you to arrange for a date to deploy the appropriate upgrade at your facility. Please distribute this information within your facility to all those who need to be aware of it. If you have any questions about this matter, please contact your local Agfa HealthCare organization 1-866-599-3868 and please reference Problem Record PRB0056200 and Vigilance Record VR0000568.
Quantity 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA HEALTHCARE N.V.
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