Reported Jul 5, 2017 · Terminated
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that…
AGFA Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Healthcare Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- 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
- Lot codes and dates
Versions CV 12.2 SU3CV 12.2 SU4CV 12.2 SU5 and CV 12.2 SU6
- Amount recalled
- 10
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new AGFA Healthcare Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.