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Terminated

Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.

FDA Recall Z-0163-2009 · Posted 2008-10-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2008-08-25
Date Terminated2008-10-20
Product Quantity7 units

Reason for Recall

Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.

Firm Action

Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.

Root Cause

Equipment maintenance

Distribution Pattern

Nationwide distribution including states of CA, IN, KY, UT, VA and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013826AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)Siemens Medical Systems, Inc. · 2002-02-01

Official Source

View FDA Recall →

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

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