IMPAX RIS QDOC 5 — Class II medical device recall Z-0919-2014
Terminated recall by AGFA Corp., reported 2014-02-12, distributed in CA, FL, GA, ME, OH, OR, SC, SD…. Patient name displayed (printed) on the Patient Report was the wrong patient name.
| Recall number | Z-0919-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Corp., Greenville, SC, United States |
| Recall initiated | 2014-01-08 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-02-28 |
| Distributed | CA, FL, GA, ME, OH, OR, SC, SD, TX |
| Countries outside the US | CA |
| Quantity | 14 |
Product
IMPAX RIS QDOC 5.8
Reason for recall
Patient name displayed (printed) on the Patient Report was the wrong patient name.
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-0919-2014. 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.