IMPAX Cardiovascular The IMPAX CV Reporting module consists of a… — Class II medical device recall Z-2652-2017
Terminated recall by AGFA Healthcare Corp., reported 2017-07-05, distributed nationwide. A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the N
| Recall number | Z-2652-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2016-12-22 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2021-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | software |
Product
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Reason for recall
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
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-2652-2017. 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.