Mammomat Inspiration full — Class II medical device recall Z-1118-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-02-08, distributed nationwide. Software error
| Recall number | Z-1118-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2017-01-11 |
| Classified | 2017-01-31 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 55 units |
| Reason classes | software |
| Serial numbers | 2098, 3088, 3118, 3122, 3243, 4018, 4161, 4214, 4520, 4525, 4556, 4571, 4709, 5018, 5042, 6045, 6080, 6093, 6246, 6259, 6288, 6306, 6344, 6394, 6412 and 30 more |
| Model numbers | 10140000 |
Product
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.
Reason for recall
Software error
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.