IMPAX CV 7 — Class II medical device recall Z-1069-2013
Terminated recall by AGFA Corp., reported 2013-04-17, distributed in FL, KY. Software design error in IMPAX CV 7.8 SU3
| Recall number | Z-1069-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Corp., Greenville, SC, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-04-08 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2014-04-01 |
| Distributed | FL, KY |
| Quantity | 2 |
| Reason classes | software |
Product
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
Reason for recall
Software design error in IMPAX CV 7.8 SU3
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-1069-2013. 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.