Z-0101-2019 Class II Terminated
FDA device recall Z-0101-2019 was initiated by Agfa Healthcare NV on Aug 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 3, 2020). Affected quantity: 17.
Recall details
- Product Type
- Devices
- Report Date
- Oct 17, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Apr 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
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.
Distribution pattern
US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0101-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026