FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Definition Edge; intended 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 angles or spiral planes taken at different angles.
- Recall number
- Z-0019-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Definition Edge; intended 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 angles or spiral planes taken at different angles.
- Status
- Terminated
- Initiated
- 2015-08-14
- Posted
- 2015-10-05
- Terminated
- 2016-12-05
- Reason
- software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
- Root cause
- Software design
- Action
- A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.
- Quantity
- 113 total
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279
- 510(k) numbers
- ["K143401"]
- 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