Agfa Healthcare Recalls IMPAX CV Software for Incorrect PDF Reports
Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.
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 source text describes a software defect resulting in incorrect PDF reports without any mention of patient injury, hospitalization, or death. This aligns with a moderate severity for a data integrity issue in a medical device.
Plain-English summary
Agfa Healthcare Corp. is recalling 19 units of the IMPAX Picture Archive and Communications System (PACS) software, specifically versions 7.8.x and 12.x. The recall involves the Demographics Manager (DM) feature, which is used to correct demographic information such as patient name, medical record number, and accession number in previously signed reports.
The recall was initiated because customers reported that the software did not produce correct PDF reports after the reports were signed by a physician, even though the reports were correct at the time of signature. This issue affects the accuracy of the final archived documents.
The affected software was distributed in the states of California, Kentucky, New Hampshire, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, and Washington, as well as in Canada. Customers who have this software should contact Agfa Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
- Manufacturer
- AGFA Healthcare Corp.
- Category
- Medical Device — Software
- Affected units
- 19
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)
- Model # L9M2100
Distribution
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