FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MAMMOMAT Inspiration Full field digital mammographic x-ray system
- Recall number
- Z-0523-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MAMMOMAT Inspiration Full field digital mammographic x-ray system
- Status
- Terminated
- Initiated
- 2011-09-15
- Posted
- 2012-01-11
- Terminated
- 2014-03-05
- Reason
- Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient. The movement of the swivel arm may also cause an injur
- Root cause
- Use error
- Action
- Siemens Medical Solutions USA, Inc sent a Safety Advisory Notice dated January 8, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The notification included an Addendum to the User Manual. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your operating personnel accordingly. Please ensure that this safety advisory is placed in the System's Operator Manual. Your operating personnel should maintain awareness over an appropriate defined period. Further questions please call (610) 219-4834.
- Quantity
- 12
- Distribution
- Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC.
- Lot, serial or model codes
- Model number 10140000
- 510(k) numbers
- not on file
- PMA numbers
- ["P030010S006"]
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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