Recall Z-1502-2020— Agfa N.V.
Class II · Terminated
Class II FDA medical device recall by Agfa N.V., initiated 2020-02-10, terminated 2023-03-30. It names one FDA 510(k) clearance: K183275. Product: 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: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures..
- Recalling firm
- Agfa N.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-10
- Terminated
- 2023-03-30
- Firm location
- Mortsel, Belgium
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.