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U.S. Department of Health and Human Services

Class 2 Device Recall Mammomat Inspiration system

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  Class 2 Device Recall Mammomat Inspiration system see related information
Date Initiated by Firm October 28, 2014
Date Posted December 06, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall Number Z-0523-2015
Recall Event ID 69686
510(K)Number K122286  
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
Product Mammomat Inspiration system:

Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Code Information model number: 10140000
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 determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.
FDA Determined
Cause 2		 Use error
Action A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.
Quantity in Commerce 3
Distribution US Nationwide Distribution in the state of: WV, NY, and FL..
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 = MUE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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