FDA recall Z-2652-2017

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 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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2016-12-22

Report date

2017-07-05

Termination date

2021-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2652-2017