FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
- Recall number
- Z-2812-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
- Status
- Terminated
- Initiated
- 2015-08-05
- Posted
- 2015-09-24
- Terminated
- 2016-09-01
- Reason
- A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
- Root cause
- Software design (manufacturing process)
- Action
- Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues.
- Quantity
- 26
- Distribution
- Worldwide Distribution and US Nationwide
- Lot, serial or model codes
- ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression 07360717 PRIMUS - K993425 PRIMUS Plus 04504200 Syngo RT Therapist - 08162815 serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419
- 510(k) numbers
- ["K031764","K060226","K090683","K103606","K993425"]
- 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