AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a… — Class II medical device recall Z-1502-2020
Terminated recall by Agfa N.V., reported 2020-03-25, distributed nationwide. Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
| Recall number | Z-1502-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa N.V., Mortsel, Belgium |
| Recall initiated | 2020-02-10 |
| Classified | 2020-03-18 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2023-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Serial numbers | 00949, 1161 |
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 for recall
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1502-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.