Agfa Digital Radiography X-Ray System Recalled for Mislabeled Output Power
AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit in West Virginia because it was mislabeled with a factory label showing 32 KW output power.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling error with no reported harm.
Plain-English summary
AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit. The recall is limited to a single unit with serial number A5410000042 that was distributed in the state of West Virginia.
The recall was initiated because the unit was mislabeled with a factory label showing 32 KW output power. The source text does not specify the correct output power or the nature of the discrepancy beyond the presence of the incorrect label.
The source text does not provide specific instructions for consumers or healthcare facilities regarding the next steps for this recall. No illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
- Manufacturer
- AGFA Healthcare Corp.
- Hazard
- Affected units
- 1
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)
- Serial Number A5410000042
Distribution
Distributed in 1 state:
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