FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA Inc.: Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Recall number
- Z-0807-2015
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Product
- Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Status
- Terminated
- Initiated
- 2014-11-13
- Posted
- 2014-12-16
- Terminated
- 2015-07-09
- Reason
- Possibility for system display freeze during CT interventional procedures.
- Root cause
- Software design
- Action
- The firm initiated their recall by certified mail on 11/13/2014.
- Quantity
- 4 units
- Distribution
- Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
- Lot, serial or model codes
- Serial Numbers: 11002, 11005, 11006, 11008
- 510(k) numbers
- ["K123737"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1034973
- Firm city
- Knoxville
- Firm state
- TN
- 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