FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
- Recall number
- Z-1246-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
- Status
- Terminated
- Initiated
- 2019-02-14
- Posted
- not on file
- Terminated
- 2020-05-01
- Reason
- Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
- Root cause
- Software design
- Action
- Siemens issued letter dated 2/14/19 providing reason for recall and a user workaround in the Customer Safety Advisory Notice (CSAN) CT006/19/S. The recall issue will be permanently resolved by software update syngo CT VB10A_SP1. Contact the service organization 1-800-888-7436.
- Quantity
- 53 total units distributed in U.S.
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Serial numbers of all affected models: 122022 100143 100107 83834 83746 83811 66649 122020 83801 122008 122029 83767 83852 100092 83798 100091 100112 100129 100136 83837 122023 83871 100117 100097 100099 122009 83763 83819 83752 83845 83846 83749 83847 100146 83786 83842 83775 100090 83796 83768 83859 100087 83826 83754 83790 122011 83824 100147 83810 83758 100140 100085 83808
- 510(k) numbers
- ["K173607"]
- 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