Reported Jun 10, 2020 · Terminated
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa…
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
- Type number6010/200 -
- Product UsageDR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence)
- of the following 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
- Serial Numbers
092509450948094910031022111611361161122912391401and 1404
- Serial Numbers
- Amount recalled
- 13 units
Where it was sold
Why it was recalled
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
This product could cause temporary or reversible health problems — stop using it.
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