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Terminated

Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.

FDA Recall Z-0128-2009 · Posted 2008-11-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2008-09-02
Date Terminated2009-10-05
Product Quantity46 units

Reason for Recall

Incorrect contour finding: Image may be calibrated to the wrong size catheter.

Firm Action

Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.

Root Cause

Software design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021021MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTISSiemens Medical Solutions USA, Inc. · 2002-06-06K010721AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMSiemens Medical Corp. · 2001-03-30

Official Source

View FDA Recall →

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

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