Mammomat Inspiration system recallZ-0523-2015 · Siemens Medical Solutions USA, Inc · initiated Oct 28, 2014
Class II Terminated All recalls posted in December 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
It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.
FDA root cause category: Use error
What the company is doing
A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.
Recall details
- Recall number
- Z-0523-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 28, 2014
- Posted by the FDA
- Dec 6, 2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3
- Product code
- MUE
- FDA submissions
- K122286
- Distribution
- US Nationwide Distribution in the state of: WV, NY, and FL..
Product description
Mammomat Inspiration system: Product Usage: 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.
Code information (models, lots, serial numbers)
model number: 10140000
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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