AGFA IMPAX RIS QDOC 5.8 Software Recall for Incorrect Patient Names
AGFA Corp. is recalling IMPAX RIS QDOC 5.8 software because patient reports may display the wrong patient name.
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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
AGFA Corp. is recalling 14 units of IMPAX RIS QDOC 5.8 software. The recall was initiated because the patient name displayed and printed on the Patient Report was the wrong patient name.
The affected software is version 5.8 and higher. The units were distributed to locations in California, Florida, Georgia, Maine, Ohio, Oregon, South Carolina, South Dakota, Texas, and Canada.
Consumers and healthcare providers should contact AGFA Corp. for further instructions regarding the recall.
The recalled product
- Product
- IMPAX RIS QDOC 5.8
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 14
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)
- Software IMPAX RIS 58 and higher
Distribution
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