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
Reported: July 5, 2017 Initiated: December 22, 2016 #Z-2652-2017
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.
Details
- Recalling Firm
- AGFA Healthcare Corp.
- Units Affected
- 10
- Distribution
- Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
- Location
- Greenville, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AGFA Healthcare Corp.. Units affected: 10.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2017. Severity: Moderate. Recall number: Z-2652-2017.
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