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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens RAD Fluoro Uro

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 Class 2 Recall
Siemens RAD Fluoro Uro
see related information
Date Posted June 21, 2014
Recall Status1 Terminated on February 24, 2015
Recall Number Z-1845-2014
Recall Event ID 66315
Premarket Notification
510(K) Number
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Code Information Model numbers 10094910, 10281013, and 10281163 with software version VB10G.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Siemens Customer Service
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 76
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.