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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Recall Number Z-1070-2013
Classification Class II
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
Product Distributed Qty 26
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.

Event Detail

Event Id 64656
Product Type Devices
Status Ongoing
Recalling Firm AGFA Corp.
City Greenville
State SC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.