FDAJune 27, 2019device
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, gastro-intestinal ex...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
What to do
FDA enforcement status: Terminated
Brands named
agfa n vagfa
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 8002025-11-18
- FDAEnterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8....2024-09-06
- FDADR 800. Digital Radiography X-ray System.2024-07-29
- FDAAgfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 04002024-02-23
- FDAAgfa HealthCare Enterprise Imaging XERO Viewer2022-12-05
- FDAAGFA 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 fluoroscopy proced...2020-04-06
- FDAAGFA 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 applications2020-02-10
- FDAPET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different ...2019-01-25
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