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Terminated

Axiom Artis System

FDA Recall Z-0848-04 · Posted 2004-07-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2003-05-28
Date Terminated2004-08-25
Product Quantity46 units

Reason for Recall

patient images misidentified

Firm Action

The recalling firm issued recall letters dated 5/28/03 to their accounts informing them of the problem.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010721AXIOM 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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