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Terminated

SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system.

FDA Recall Z-2222-2010 · Posted 2010-08-13

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-07-13
Date Terminated2012-09-29
Product Quantity1296

Reason for Recall

Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.

Firm Action

Siemens Healthcare Sector sent an "Urgent Field Safety Notice" to consignees describing the issue and informing them to take specific precautions when performing interventional procedures to avoid fluids penetrating the system. The multi-functional handle (Opti Grip) will be replaced through implementation of Update Instructions AX030/10/S. The modified version of the handle resists fluids from entering the handle and prevents malfunction.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution: all 50 US states and PR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062623AXIOM LUMINOS DRFSiemens Medical Solutions USA, Inc. · 2007-08-22K051602AXIOM SIRESKOP SDSiemens Medical Systems, Inc. · 2005-07-07

Official Source

View FDA Recall →

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

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