# FDA recall Z-0101-2019

> **Agfa Healthcare NV** · Class II · device recall initiated 2018-08-03.

## 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 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

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

## Key facts

- **Recall number:** Z-0101-2019
- **Recalling firm:** Agfa Healthcare NV
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-03
- **Report date:** 2018-10-17
- **Termination date:** 2020-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mortsel, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0101-2019

## Citation

> AI Analytics. FDA recall Z-0101-2019. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0101-2019. Source: US FDA. Licensed CC0.

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