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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems

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  Class 2 Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems see related information
Date Initiated by Firm July 07, 2014
Date Posted September 10, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-2292-2014
Recall Event ID 68785
510(K)Number K062623  K081722  K101491  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Siemens Luminos dRF, Ysio or Uroskop Omnia systems.

The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Code Information model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi
FDA Determined
Cause 2		 Device Design
Action Siemens had informed all affected customers about this issue via Customer Safety Advisory Notice XP023/13/S (dated June 3, 2013) reported under C&R # 2240869-05/16/13-0013-C. A corresponding software update to fix the issue was originally planned to be rolled out by May 2014. The originally scheduled roll out date could not be met and to ensure that this new software version works accurately Siemens incorporated a comprehensive monitoring phase. Siemens has now scheduled the roll out for the software version VB10J to be completed by end of October 2014. A letter, dated July 7, 2014, with important safety information was sent to end users to notify them that the new software version VB10J will be introduced to solve the potential malfunction of the generator.
Quantity in Commerce 192
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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