FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-0086-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-09-18
- Posted
- 2014-10-17
- Terminated
- 2015-02-24
- Reason
- 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
- Root cause
- Process control
- Action
- A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.
- Quantity
- 3
- Distribution
- US Distribution in states of: NY, VA, and MA.
- Lot, serial or model codes
- material #10140000, with serial numbers: 5018 3849 5042
- 510(k) numbers
- ["K122286"]
- PMA numbers
- not on file
- Product code
- MUE
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28