FDAFDA · Food and drugs·Recall number Z-1502-2020
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Published March 25, 2020 · Recall initiated: February 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Agfa N.V.
- Distributor
- US Nationwide distribution in the states of FL, VA.
- Lot
- Serial Numbers: 00949, 1161
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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