Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2652-2017 — 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

U.S. FDA — Device Enforcement · United States · 2016-12-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2652-2017
Date of alert
2016-12-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
AGFA Healthcare Corp.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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