IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
FDA Recall Z-1070-2013 · Posted 2013-04-08
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-03-15
Date Terminated2014-01-09
Product Quantity26
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.
Firm Action
AGFA sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013 to the consignees who use the IMPAX CV Reporting tool described for this issue. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 877-777-2432, referencing HQ_10020006 for questions regarding this notice.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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