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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Recall Number Z-2184-2012
Classification Class II
Code Info Model # L9M2100 - All Software versions of IMPAX CV Reporting
Product Distributed Qty 280
Reason For Recall Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

Event Detail

Event Id 62646
Product Type Devices
Status Ongoing
Recalling Firm AGFA Corp.
City Greenville
State SC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Canada