FDAJanuary 25, 2019device
PET 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 frequencies and intensities
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
- FDAAGFA 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...2019-06-27
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