AGFA Healthcare Corp.: Medical Device Recall in 2017 - (Recall #: Z-2652-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 22, 2016

Date Posted: July 5, 2017

Recall Number: Z-2652-2017

Event ID: 77629

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.

Status: Terminated

Product Quantity: 10

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

Voluntary or Mandated:

Voluntary: Firm initiated