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 | System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. |
| Product | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). |
| Quantity | 4 |
| Distribution | Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada. |
| Initiated | 2013-09-19 |
| Classified | 2013-10-21 |
| Terminated | 2013-10-24 |
| Recall number | Z-0035-2014 |
| 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-0035-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66424/
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