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Terminated

AXIOM Artis MP, Angiographic x-ray system, model number 5904466

FDA Recall Z-0578-2007 · Posted 2007-03-08

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2007-01-31
Date Terminated2009-05-05
Product Quantity62 units

Reason for Recall

C-arm gantry could rapidly descend without command during use.

Firm Action

In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.

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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