IMPAX Cardiovascular — Class II medical device recall Z-2184-2012
Terminated recall by AGFA Corp., reported 2012-08-22, distributed nationwide. Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the fi
| Recall number | Z-2184-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Corp., Greenville, SC, United States |
| Recall initiated | 2012-07-27 |
| Classified | 2012-08-10 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2015-01-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 280 |
| Model numbers | L9M2100 |
Product
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Reason for recall
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
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-2184-2012. 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.