FDA Device recall Z-1118-2017
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammograp…
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammograp… by Siemens Medical Solutions Usa, citing software error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1118-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-11 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
Software error
Identifiers
| code_info | Device Model # 10140000 Serial Numbers: 4709 6616 6571 6602 6761 6573 4520 4556 6567 6424 6306 6757 6560…Device Model # 10140000 Serial Numbers: 4709 6616 6571 6602 6761 6573 4520 4556 6567 6424 6306 6757 6560 6524 6412 6442 5018 6675 8038 6575 6045 3122 6871 3243 4571 6259 6469 6676 6474 6640 6452 6561 6801 2098 4161 6483 6344 6288 6594 8002 6610 6394 4018 6502 6080 4214 6893 6093 3118 6601 5042 6246 3088 4525 6870 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2017%22
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