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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens RAD Fluoro Uro Systems

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  Class 2 Device Recall Siemens RAD Fluoro Uro Systems see related information
Date Initiated by Firm May 06, 2013
Date Posted November 01, 2013
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-0016-2014
Recall Event ID 65161
510(K)Number K062623  K081722  K101491  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E.

Fluroscopic X-Ray Systems
Code Information Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114.
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		 Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho
FDA Determined
Cause 2		 Software design
Action Siemens initiated this correction on May 6, 2013 by sending Update InstructionXP005/13/S. Firm subsequently issued a letter on June 3, 2013 to all accounts. 1. Siemens Field Modification of the Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, which improves the signal transmission for the automatic exposure control, is available as of May 2013, and systems will be updated within one year. 2. The revised software fix for models Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, will be provided to all identified customers at no charge. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Siemens Medical Solutions USA, Inc., will notify the FDA district office in Philadelphia, Pennsylvania, with reports of progress regarding this field correction.
Quantity in Commerce 23
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 = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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