FDA Device recall Z-2184-2012
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet c…
- FDA Device
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet c… by Agfa, citing content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2184-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-27 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | US |
Product
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Reason
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Identifiers
| code_info | Model # L9M2100 - All Software versions of IMPAX CV Reporting |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2184-2012%22
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