Agfa Healthcare Recalls Two IMPAX Agility Medical Imaging Systems
Agfa Healthcare is recalling two IMPAX Agility PACS units in Missouri due to a software error that displayed incorrect patient names.
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. The hazard involves a software error leading to incorrect patient name display, which is a significant data integrity issue but does not involve a direct physical injury or high-risk pathogen.
Plain-English summary
Agfa Healthcare Corp. is recalling two units of the IMPAX Agility Picture Archiving and Communication System (PACS). The recall is limited to units distributed in the state of Missouri.
The recall was initiated after the firm received a complaint that the system displayed an incorrect patient name. This occurred when a hospital sent two accession numbers on the same morning, causing a data mismatch on the Agility interface.
The IMPAX Agility system is used to acquire, display, process, and store multimodality medical images and reports for diagnostic purposes. No specific instructions for consumers are provided in the source text, as the product is a professional medical device.
The recalled product
- Product
- IMPAX Agility. IMPAX Agility 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…
- Manufacturer
- AGFA Healthcare Corp.
- Affected units
- 2
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
Distributed in 1 state:
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