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Terminated

Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI

FDA Recall Z-1349-2008 · Posted 2008-03-31

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-02-22
Date Terminated2010-07-27
Product Quantity5 units

Reason for Recall

Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.

Firm Action

All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.

Root Cause

Software design

Distribution Pattern

Nationwide to five hospitals in DC, NY, OH, TN, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050228AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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