FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Recall number
- Z-0971-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Status
- Terminated
- Initiated
- 2014-12-03
- Posted
- 2015-01-14
- Terminated
- 2015-04-06
- Reason
- Artifacts are found in acquired imaging on the SOMATOM Force.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.
- Quantity
- 7
- Distribution
- PA, MA, MN, SC, MD, and TX.
- Lot, serial or model codes
- Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.
- 510(k) numbers
- ["K133589"]
- PMA numbers
- not on file
- Product code
- JAK
- 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