MAMMOMAT Inspiration recallZ-1638-2014 · Siemens Medical Solutions USA, Inc · initiated Apr 25, 2014
Class II Terminated All recalls posted in May 2014
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
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.
FDA root cause category: Device Design
What the company is doing
A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
Recall details
- Recall number
- Z-1638-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 25, 2014
- Posted by the FDA
- May 20, 2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 5
- Product code
- MUE
- FDA submissions
- K122286
- Distribution
- Distributed in the states of GA, FL, NY, NV, and MA.
Product description
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Code information (models, lots, serial numbers)
(Material number 10549894) with serial numbers 5000 through 5029.
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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