FDAClass IIAugust 22, 2012

IMPAX Cardiovascular recall

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet…

Why was IMPAX Cardiovascular recalled?

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

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?

Model # L9M2100 - All Software versions of IMPAX CV Reporting

Product
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet…
Recalling firm
AGFA Corp.
Quantity
280
Distribution
Worldwide Distribution - USA (nationwide) and Canada
Recall date
August 22, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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