FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
- Recall number
- Z-3005-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
- Status
- Terminated
- Initiated
- 2020-08-19
- Posted
- not on file
- Terminated
- 2023-04-19
- Reason
- Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
- Root cause
- Software design
- Action
- Siemens Medical Solutions USA, Inc. issued Customer Safety Advisory Letter (CSAN) SY051/20/S on August 19, 2020 via email/hand delivery by Siemens Customer Service Engineer,. The letter states reason for recall, health risk and action to take: we highly recommend performing the laser calibration and the quality assurance procedure for the laser offset after every RT Image Suite software update.Please update the calibration offset in the MM RT Image Suite Configuration dialog accordingly . Details of this procedure are documented in Chapter 13.2 (Laser configuration) of your user manual. If you have any questions or require technical support, please contact our service organization at 1-800-888-7436. The technical solution distributed via SY040/20/S. Distribution of SY040/20/S (VB40B_HF01) will be distributed to all affected customers, free of charge. Distribution of SY040/20/S began on August 26, 2020. SY040/20/S will be installed with support from your local service organization
- Quantity
- 64 systems US
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Serial Numbers: 100418 100419 100420 100421 100641 100642 100643 100644 100645 100704 100713 100735 100811 100812 100813 100814 101724 102013 102031 102108 102305 102369 130125 130140 130331 130335 130628 130751 130848 130874 131012 131169 131247 131284 131325 131336 131360 131503 131578 131589 131801 131966 132011 132061 132102 132108 132136 132231 132595 132729 222224 222411 222417 222475 222491 222539 222563 222601 222638 222686 222946 223004 223084 451001
- 510(k) numbers
- ["K192065"]
- PMA numbers
- not on file
- Product code
- MUJ
- 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