Recall Z-1070-2013— AGFA Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Corp., initiated 2013-03-15, terminated 2014-01-09. It names one FDA 510(k) clearance: K050228. 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..
- Recalling firm
- AGFA Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-15
- Terminated
- 2014-01-09
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.