Agfa IMPAX 5.2 DB Server Software Recall for Performance Issues
Agfa Corp. is recalling IMPAX 5.2 DB Server software because older versions may cause system downtime or slow performance in medical imaging systems.
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 limited to system downtime and slow performance without reports of injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Agfa Corp. is recalling four units of the IMPAX 5.2 DB Server software, which runs on Oracle 10.1.0.4.0 and functions as a medical imaging Picture Archiving and Communication System (PACS). The recall is due to the risk that using an old version of the software that is not at current supported levels may result in system downtime and/or slow performance.
The affected software was distributed worldwide, including nationwide distribution in the United States (specifically noting New York and Oklahoma) and in Canada. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare facilities using this software should verify their version levels to ensure they are running current supported versions to avoid potential system downtime or performance issues.
The recalled product
- Product
- IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
- Manufacturer
- AGFA Corp.
- Affected units
- 4
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 (1)
- N/A
Distribution
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