Agfa Healthcare Recalls Enterprise Imaging Desktops Due to Sorting Error
Agfa Healthcare is recalling 17 Enterprise Imaging Desktops because adding a comparison study may disrupt the chronological sorting of images in the Clinical Side Bar.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software sorting error that does not explicitly report injuries, hospitalizations, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Agfa Healthcare NV is recalling 17 units of Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) under FDA recall number Z-0101-2019. The affected software versions include 8.0.0, 8.0.1, and 8.1, along with their respective service packs.
The recall is issued because adding an additional comparison study to the Clinical Side Bar can result in a change to the sort order of the studies. Specifically, the thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top. This issue affects the display of multimodality medical images, reports, and demographic information used for diagnostic purposes.
The affected units were distributed in the United States to California, Florida, Indiana, Louisiana, Minnesota, Pennsylvania, South Carolina, Texas, Virginia, and Puerto Rico, as well as internationally to Canada. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- 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…
- Manufacturer
- Agfa Healthcare NV
- Category
- Medical Device — Software
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
Distribution
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