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Terminated

Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system

FDA Recall Z-1845-2014 · Posted 2014-06-21

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2013-08-28
Date Terminated2015-02-24
Product Quantity76

Reason for Recall

When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.

Firm Action

Siemens sent a notification letter, dated August 28, 2013, to Affected customers. The letter identified the affected product, problem and actions to be taken. The letter provided work-around instructions and announced that a field modification was prepared to resolve the issue.

Root Cause

Software design

Distribution Pattern

USA Nationwide Distribution in the states of OH, NJ, MA, CO, NY, CA, MD, OR, KY, PA, IL, VA, TX, MN, KS, GA, and WY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101491UROSKOP 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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