IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
FDA Recall Z-2184-2012 · Posted 2012-08-10
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-07-27
Date Terminated2015-01-13
Product Quantity280
Reason for Recall
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Firm Action
AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood.
For questions customers were instructed tol call 401-604-2180.
For questions regarding this recall call 864-421-1754.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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