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Terminated

Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)

FDA Recall Z-1159-2012 · Posted 2012-03-05

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-02-15
Date Terminated2014-01-14
Product Quantity58

Reason for Recall

Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the image pipeline, images may display dark and not suitable for diagnostic. Due to this software error customers have to repeat x-ray exposure to receive diagnostic images.

Firm Action

Siemens sent Update Instruction XP057/11/S by mail on February 15, 2012, which releases software update package VC10D to remedy the described issues. For questions regarding this recall call 610-219-4834.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including AK, CA, CO, FL, GA, IL, IN, IA, KY, MD, MA, MO, NE, NY, NC, OH, OR, PA, SC, TX, and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111292LUMINOS AGILESiemens Medical Solutions USA, Inc. · 2011-06-03K101491UROSKOP OMNIASiemens Medical Solutions USA, Inc. · 2010-06-30K081722YSIOSiemens Medical Solutions USA, Inc. · 2008-08-22K062623AXIOM LUMINOS DRFSiemens Medical Solutions USA, Inc. · 2007-08-22

Official Source

View FDA Recall →

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

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