AGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction
AGFA Corp. is recalling 216 DX-D 100 digital radiography systems because liquid contact with the touch screen may cause the device to incorrectly recognize user input and alter settings.
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 hazard involves potential alteration of device settings due to liquid contact, which is a functional defect without reported injuries or hospitalizations.
Plain-English summary
AGFA Corp. is recalling 216 units of the AGFA Digital Radiography X-Ray system DX-D 100. The recall is due to a defect where liquid coming into contact with the device's touch screen may cause the system to incorrectly recognize the liquid as user input, potentially altering device settings.
The affected units were distributed nationwide in the United States and internationally to Canada. The specific states listed in the distribution pattern include AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, and WY.
Healthcare facilities should identify affected units by checking the serial numbers provided in the recall notice. The DX-D 100 is indicated for providing diagnostic quality images to aid physicians with diagnosis, including radiographic images of the skeleton, chest, and abdomen, but is not indicated for use in mammography.
The recalled product
- Product
- AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spi
- Manufacturer
- AGFA Corp.
- Affected units
- 216
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 (20)
- Serial # A5410000053
- A5410000054
- A5410000067
- A5410000068
- A5410000069
- A5410000070
- A5410000072
- A5410000073
- A5411000315
- A5411000331
- A5411000332
- A5411000141
- A5411000144
- A5411000038
- A5411000069
- A5411000133
- A5411000175
- A5411000119
- A5411000123
- A5411000333
Distribution
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