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.
FDA Recall Z-0523-2015 · Posted 2014-12-06
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUE
Date Initiated2014-10-28
Date Terminated2015-07-20
Product Quantity3
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.
Firm 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.
Root Cause
Use error
Distribution Pattern
US Nationwide Distribution in the state of: WV, NY, and FL..
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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