IMPAX 5 — Class II medical device recall Z-0035-2014
Terminated recall by AGFA Corp., reported 2013-10-30, distributed nationwide. System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at
| Recall number | Z-0035-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Corp., Greenville, SC, United States |
| Recall initiated | 2013-09-19 |
| Classified | 2013-10-21 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2013-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4 |
| Reason classes | software |
Product
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Reason for recall
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.
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-0035-2014. 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.