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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 Device Recall Siemens RAD Fluoro Urosee related information
Date Initiated by FirmAugust 28, 2013
Date PostedJune 21, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall NumberZ-1845-2014
Recall Event ID 66315
510(K)NumberK062623 K081722 K101491 
Product Classification System, x-ray, stationary - Product Code KPR
ProductSiemens 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/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactSiemens Customer Service
610-219-6300
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		Software design
ActionSiemens 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 Commerce76
DistributionUSA 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR
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