Recall Z-2652-2017— AGFA Healthcare Corp.

Name: FDA recall Z-2652-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-22

Class II · Terminated

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2016-12-22, terminated 2021-08-27. It names one FDA 510(k) clearance: K050228. 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. 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..

Recalling firm: AGFA Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-12-22
Terminated: 2021-08-27
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K050228 — AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc.·cleared 2005-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.