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Recall Observatory FDA recall evidence

Device product

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

Z-1070-2013

March 15, 2013

Class II

Product summary

Firm
AGFA Corp.
Event
Event 64656
Status
Terminated
Classification
Class II
Quantity
26
Official record key
device-enforcement:Z-1070-2013

Official wording

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.

Code information: 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

Distribution pattern: Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.