Agfa DR 800 X-Ray System Recalled for Dose Calculation Error
Agfa N.V. is recalling 13 DR 800 digital radiography systems because a software error may cause incorrect dose calculations during specific fluoroscopic exams.
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 3/5 (High).
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 involves a risk-of-harm product (radiation dose calculation error) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Agfa N.V. is recalling 13 units of the AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic (Type number: 6010/200). The recall affects specific serial numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404. These units were distributed nationwide in the United States, including in Florida, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Ohio, South Carolina, Virginia, and Wisconsin.
The recall is due to a potential software defect where the system may incorrectly calculate the dose per minute for fluoroscopy exams. This error can occur under specific conditions: during a fluoroscopic exam, when the automatic brightness stabilization (ABS) is turned off, and when parameters are manually changed. The DR 800 system is indicated for dynamic imaging examinations such as positioning fluoroscopy, gastro-intestinal examinations, urogenital tract examinations, and angiography, as well as project radiography of all body parts, but is not intended for mammography.
Healthcare facilities and users should contact Agfa N.V. for instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning…
- Manufacturer
- Agfa N.V.
- Affected units
- 13
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 (13)
- Serial Numbers: 0925
- 0945
- 0948
- 0949
- 1003
- 1022
- 1116
- 1136
- 1161
- 1229
- 1239
- 1401
- and 1404
Distribution
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