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
Reported: March 25, 2020 Initiated: February 10, 2020 #Z-1502-2020
Product Description
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
Reason for Recall
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Details
- Recalling Firm
- Agfa N.V.
- Units Affected
- 2 units
- Distribution
- US Nationwide distribution in the states of FL, VA.
- Location
- Mortsel
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Agfa N.V.. Units affected: 2 units.
Why was this product recalled? ▼
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1502-2020.
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