FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
- Recall number
- Z-0406-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
- Status
- Terminated
- Initiated
- 2019-10-07
- Posted
- not on file
- Terminated
- 2022-11-14
- Reason
- Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
- Root cause
- Software design
- Action
- Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice (CSAN) to all affected customers via CT070/19/S. on 10/719 via email/or letter. The CSAN provides recommendations to avoid the issues until the technical solution can be applied. The issues will be resolved with software update version syngo CT VB20_SP1 (Service Pack 1). You will receive the updated software free of charge. Questions or require technical support, please contact the service organization at 1-800-888-7436.
- Quantity
- 305 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Software versions syngo CT VB20
- 510(k) numbers
- ["K103127","K121072","K133589","K142955","K161196","K173630"]
- 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