FDA Device recall Z-1638-2014
MAMMOMAT Inspiration
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of MAMMOMAT Inspiration by Siemens Medical Solutions Usa, citing there is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1638-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-25 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | FL, GA, MA, NV, NY |
Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Reason
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
Identifiers
| code_info | (Material number 10549894) with serial numbers 5000 through 5029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1638-2014%22
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