FDA Device recall Z-1070-2013
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting by Agfa, citing baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic heal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1070-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | US |
Product
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Reason
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.
Identifiers
| code_info | Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL |
|---|
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-1070-2013%22
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