Agfa DR 800 Digital Radiography System Recalled for Image Mismatch
Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.
What this means for you
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, and the source text describes a technical defect regarding image area mismatch without reporting any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Agfa N.V. is recalling four units of the AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic. The affected units are identified by model/serial numbers 00925, 00945, 00949, and 1136. These devices were distributed nationwide in the United States.
The recall was initiated because the exposed area of fluoroscopic examinations may not match the active area of the detector within specified limits. This discrepancy could affect the accuracy of the imaging data collected during dynamic imaging procedures such as positioning fluoroscopy, gastro-intestinal examinations, urogenital tract examinations, and angiography.
Healthcare facilities and users of these systems should stop using the affected units and contact Agfa N.V. for further instructions on repair or replacement. The DR 800 system is intended for dynamic imaging and project radiography but is not intended for mammography applications.
The recalled product
- Product
- AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures,
- Manufacturer
- Agfa N.V.
- Category
- Medical Device — Radiography
- Hazard
- 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 (4)
- Model/Serial Number/s: 00925
- 00945
- and 00949
- 1136
Distribution
Distributed nationwide across the United States.
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