FDA Device recall Z-1502-2020
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synt…
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synt… by Agfa N V, citing tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1502-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-10 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Agfa N V |
| Distribution | US |
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.
Identifiers
| code_info | Serial Numbers: 00949, 1161 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1502-2020%22
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