Agfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error
Agfa N.V. is recalling two DR 800 X-ray systems because the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (excessive radiation exposure due to sequence error) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Agfa N.V. is recalling two units of the AGFA Digital Radiography X-Ray system DR 800 with TomoSynthesis. The recall is due to a defect where the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures. The DR 800 is a tomographic X-ray system used to synthesize tomographic slices from a single tomographic sweep and is not intended for mammography applications.
The affected units have serial numbers 00949 and 1161. These devices were distributed in the United States in the states of Florida and Virginia. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities that have these specific serial numbers should stop using the affected units and contact Agfa N.V. for further instructions on the recall.
The recalled product
- Product
- AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
- Manufacturer
- Agfa N.V.
- Hazard
- 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 (2)
- Serial Numbers: 00949
- 1161
Distribution
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