Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2652-2017 · Posted None

Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-12-22
Date Terminated2021-08-27
Product Quantity10

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.

Firm Action

AGFA Healthcare sent an Urgent Field Safety Notice dated December 22, 2016, to all affected consignees. The notice included an acknowledgement fax-back or email indicating that the information was received and understood. The notice informed the consignees of the problem and indicated that they would be contacted by Agfa Service to check the problem and to correct the NIV reporting clinical content. Customers with questions were instructed to call 1-401-330-7433. For questions regarding this recall call 864-421-1984.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050228AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑