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Terminated

Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649

FDA Recall Z-1449-04 · Posted 2004-09-14

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2004-08-10
Date Terminated2005-01-25
Product Quantity37 units

Reason for Recall

Opacification Function of device may incorrectly merge images

Firm Action

The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem.

Root Cause

Other

Distribution Pattern

The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA.

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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