Reported Mar 25, 2020 · Terminated
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage:…
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
Is this the product you have?
- AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic
- X-ray system - Product UsageTomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
- Lot codes and dates
- Serial Numbers
009491161
- Serial Numbers
- Amount recalled
- 2 units
Where it was sold
Why it was recalled
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
This product could cause temporary or reversible health problems — stop using it.
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