FDA Device recall Z-1694-2013
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
- FDA Device
- Class II
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography by Siemens Medical Solutions Usa, citing firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1694-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-28 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Reason
Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss
Identifiers
| code_info | Model number 10140000, serial numbers 3118, 3243 and 3309 |
|---|
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-1694-2013%22
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