IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user int...
FDA Recall #Z-2652-2017 — Class II — December 22, 2016
Product Description
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
Reason for Recall
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.
Recalling Firm
AGFA Healthcare Corp. — Greenville, SC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10
Distribution
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
Code Information
Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated