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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 Recall
Siemens Rad Fluoro Uro Systems
see related information
Date Posted November 26, 2013
Recall Status1 Open
Recall Number Z-0374-2014
Recall Event ID 66231
Premarket Notification
510(K) Numbers
K062623  K081722  K101491  K111292 
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, Pennsylvania 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
DESIGN: 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 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.
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