Recall StatusTerminated
Date Initiated2018-08-03
Date Terminated2020-04-03
Product Quantity17
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.