Recall Z-0101-2019— Agfa Healthcare NV

Name: FDA recall Z-0101-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-03

Class II · Terminated

Class II FDA medical device recall by Agfa Healthcare NV, initiated 2018-08-03, terminated 2020-04-03. It names one FDA 510(k) clearance: K111945. 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.. 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: Agfa Healthcare NV
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Terminated: 2020-04-03
Firm location: Mortsel, Belgium

510(k) clearances named in this recall

1 on FDA's record

K111945 — IMPAX NEXT GENERATIONAgfa Healthcare N.V.·cleared 2011-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.