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Recall Observatory FDA recall evidence

Device product

IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

Z-2652-2017

December 22, 2016

Class II

Product summary

Firm
AGFA Healthcare Corp.
Event
Event 77629
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2652-2017

Official wording

Reason: A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.

Code information: Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6

Distribution pattern: Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.