Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when Recalled by Agfa Healthcare NV Due to Adding an additional comparison study to the Clinical...

Date: August 3, 2018
Company: Agfa Healthcare NV
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Agfa Healthcare NV directly.

Affected Products

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.

Quantity: 17

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 9 states: CA, FL, IN, LA, MN, PA, SC, TX, VA

Affected (9 states)Not affected

About Agfa Healthcare NV

Agfa Healthcare NV has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report