Reported Aug 7, 2019 · Terminated
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated…
Agfa N.V.
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 N.V. · Septestraat 27 · Mortsel, N/A · N/A
Is this the product you have?
- AGFA Digital Radiography X- Ray system DR 800
- with MUSICA Dynamic Product UsageThe Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of
- the following an anatomies/procedurespositioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications
- Lot codes and dates
- Model/Serial Number/s
0092500945and 009491136
- Model/Serial Number/s
- Amount recalled
- 4
Where it was sold
- Nationwide
Why it was recalled
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
This product could cause temporary or reversible health problems — stop using it.
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