FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
- Recall number
- Z-1013-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
- Status
- Terminated
- Initiated
- 2015-01-02
- Posted
- 2015-01-26
- Terminated
- 2015-09-10
- Reason
- Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.
- Root cause
- Software Design Change
- Action
- A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.
- Quantity
- 3
- Distribution
- UT, WI, NY
- Lot, serial or model codes
- model # 08162815, serial #s 10010, 10046, 10586
- 510(k) numbers
- ["K142434"]
- PMA numbers
- not on file
- Product code
- IYE
- 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