Siemens Mammomat Inspiration - full-field digital… recallZ-1694-2013 · Siemens Medical Solutions USA, Inc · initiated Feb 28, 2013
Class II Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Device Design
What the company is doing
Siemens issued an Update Instructions XP031/12/S by letter to the affected customers. For affected sites, a Siemens Service Engineer will inspect the unit and make any adjustments needed. Following the inspection and adjustments, a proper calibration will be completed. For questions call 610-448-3237 and 610-446-4634.
Recall details
- Recall number
- Z-1694-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 28, 2013
- Posted by the FDA
- Jul 11, 2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3
- Product code
- MUE
- FDA submissions
- K122286
- Distribution
- United States Nationwide Distribution in the states of ND, OH and SC.
Product description
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Code information (models, lots, serial numbers)
Model number 10140000, serial numbers 3118, 3243 and 3309
Other devices under the same FDA submission
1 device cleared under K122286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mammomat Inspiration 10140000Siemens Healthcare GmbH · Full field digital,system,x-ray,mammographic2 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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