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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 September 03, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-0374-2014
Recall Event ID 66231
510(K)Number K081722  K111292  K062623  K101491  
Product Classification System, x-ray, stationary - Product Code KPR
Product (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10

Image intensified fluoroscopic x-ray system
Code Information Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200
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		 A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
FDA Determined
Cause 2		 Software design
Action Siemens Healthcare sent a Field Safety Notice dated September 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Field Safety Notice to any new users and provide the new owner information to Siemens Healthcare. Customers were asked to send back the attached form confirming receipt of the Field Safety Notice. Customers with questions should call 610-850-4634. For questions regarding this recall call 610-219-6300.
Quantity in Commerce 357
Distribution Worldwide Distribution - USA (nationwide) and internationally to Canada.
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 = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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