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Recall Observatory FDA recall evidence

Device 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.

Z-0101-2019

August 03, 2018

Class II

Product summary

Firm
Agfa Healthcare NV
Event
Event 80998
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-0101-2019

Official wording

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.

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.