FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
- Recall number
- Z-2269-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
- Status
- Terminated
- Initiated
- 2019-07-03
- Posted
- not on file
- Terminated
- 2024-05-10
- Reason
- Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
- Root cause
- Software design
- Action
- Siemens has initiated a Customer Safety Advisory Notice (CSAN) to all affected customers via CT035/19/S. Customers with valid email addresses were emailed a copy of the CSAN on 07/03/2019 via Adobe Mega Sign. The CSAN were distributed to the remaining customers without a valid email address via certified mail on 07/12/2019. Additionally, a solution to eliminate the root cause of this problem (application of software update VB20) will be distributed to all affected customers free of charge. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.
- Quantity
- not on file
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Serial Numbers: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823
- 510(k) numbers
- ["K120579"]
- 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