Z-0101-2019Class II

Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a...

Name: Z-0101-2019 Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a...
Creator: Agfa Healthcare NV
Published: 2018-08-03
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2018-08-03 / Terminated / root cause: software

FDA source

Agfa Healthcare NV began a recall of Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications... on 2018-08-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0101-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Posted: 2018-10-11
Terminated: 2020-04-03
Recalling firm: AGFA Healthcare Corp.
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0101-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0101-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-11

Product code LLZ

K111945Class IIImpax Next GenerationAgfa Healthcare N.V. / cleared 2011-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)