Class II — AGFA Corp.
| 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 | Patient name displayed (printed) on the Patient Report was the wrong patient name. |
| Product | IMPAX RIS QDOC 5.8 |
| Quantity | 14 |
| Distribution | CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada |
| Initiated | 2014-01-08 |
| Classified | 2014-02-03 |
| Terminated | 2014-02-28 |
| Recall number | Z-0919-2014 |
| 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 Corp. (Z-0919-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67275/
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