IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
- Company
- Agfa Corp.
- Recall Initiated
- March 15, 2013
- Posted
- April 8, 2013
- Terminated
- January 9, 2014
- Recall Number
- Z-1070-2013
- Quantity
- 26
- Firm Location
- Greenville, SC
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.
Distribution
Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
Lot / 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
Root Cause
Software design
Action Taken
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.