Siemens Mammomat Inspiration mammography systems recallZ-0086-2015 · Siemens Medical Solutions USA, Inc · initiated Sep 18, 2014
Class II Terminated All recalls posted in October 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
The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i
FDA root cause category: Process control
What the company is doing
A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.
Recall details
- Recall number
- Z-0086-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 18, 2014
- Posted by the FDA
- Oct 17, 2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3
- Product code
- MUE
- FDA submissions
- K122286
- Distribution
- US Distribution in states of: NY, VA, and MA.
Product description
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for 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)
material #10140000, with serial numbers: 5018 3849 5042
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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