IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV… — Class II medical device recall Z-1070-2013
Terminated recall by AGFA Corp., reported 2013-04-17, distributed nationwide. Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization modul
| Recall number | Z-1070-2013 |
|---|---|
| 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 | 2014-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 26 |
| Model numbers | L9M21000 |
Product
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Reason for recall
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
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-1070-2013. 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.