IMPAX Cardiovascular The IMPAX CV Reporting module recall: Software Issue
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure…
Why was IMPAX Cardiovascular The IMPAX CV Reporting module 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
- Product
- IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure…
- Recalling firm
- AGFA Healthcare Corp.
- Quantity
- 10
- Distribution
- Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
- Recall date
- July 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)