FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
- Recall number
- Z-0265-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
- Status
- Terminated
- Initiated
- 2019-09-24
- Posted
- not on file
- Terminated
- 2024-07-08
- Reason
- SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
- Root cause
- Software design
- Action
- Siemens issued a Customer Safety Advisory Notice to customers via CT072/19 on 9/24/2019. The letter identifies the problem, health risk and action to take: To avoid this issue, please refrain from using the i-Sequence scan mode in combination with the 3x3 mm collimation until this issue has been solved. Please use the i-Sequence with the 3x5 mm collimation instead, as here the correct dose information will be shown. This issue will be resolved with an improved software version syngo CT VA20A_SP2b. The software update will be released, free of charge, with the update CT073/19/S for all affected systems. The software update release is planned for Q3/2019. All future service packs will contain the update as well. Questions: contact service organization at 1-800-888-7436.
- Quantity
- 14 US
- Distribution
- US in the states of: GA, IN, MO, MS, NJ, OH, PA
- Lot, serial or model codes
- software syngo CT VA20A_SP2 and active Guide&GO license
- 510(k) numbers
- ["K173632"]
- 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