Class II — Agfa N.V.
| Recalling firm | Agfa N.V. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. |
| 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 |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of FL, VA. |
| Initiated | 2020-02-10 |
| Classified | 2020-03-18 |
| Terminated | 2023-03-30 |
| Recall number | Z-1502-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Agfa N.V. (Z-1502-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85028/
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