Reported Jul 30, 2014 · Terminated
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality…
AGFA Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- 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
- spinal column and extremitieschest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography
- Lot codes and dates
216 of 216 codes
Serial # A5410000053A5410000054A5410000067A5410000068A5410000069A5410000070A5410000072A5410000073A5411000315A5411000331A5411000332A5411000141A5411000144A5411000038A5411000069A5411000133A5411000175A5411000119A5411000123A5411000333A5411000334A5410000038A5411000019A5411000047A5411000048A5411000053A5410000041A5410000042A5410000046A5410000016A5410000039A5410000021A5410000023A5411000074A5411000080A5411000024A5411000184A5411000193A5411000196A5410000100A5410000114A5410000115A5410000116A5410000117A5411000342A5411000343A5411000344A5411000366A5411000368A5411000237A5411000027A5411000020A5411000021A5411000132A5411000070A5411000078A5411000082A5411000154A5411000156A54110000107
- Amount recalled
- 216 units
Where it was sold
Why it was recalled
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
This product could cause temporary or reversible health problems — stop using it.
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