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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 systemsee related information
Date Initiated by FirmOctober 28, 2014
Date PostedDecember 06, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall NumberZ-0523-2015
Recall Event ID 69686
510(K)NumberK122286 
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
ProductMammomat 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 ContactCustomer 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
ActionA 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 Commerce3
DistributionUS Nationwide Distribution in the state of: WV, NY, and FL..
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUE
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