Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for 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-1118-2017 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUE
Date Initiated2017-01-11
Date Terminated2017-11-29
Product Quantity55 units
Reason for Recall
Software error
Firm Action
Siemens mailed a Customer Safety Advisory Notice (CSAN) letter dated January 11, 2017 to affected customers. The letter identified the affected product, the potential risks and the steps to take to avoid the risks associated with the issue. The letter also stated Siemens will release a field modification (software update) to resolve the issue as soon as possible. The new software will be provided to affected customers free of charge.
Root Cause
Software design
Distribution Pattern
United States Nationwide Distribution
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.