FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
- Recall number
- Z-2789-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
- Status
- Terminated
- Initiated
- 2011-05-25
- Posted
- 2011-07-11
- Terminated
- 2012-03-01
- Reason
- Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
- Root cause
- Software design
- Action
- Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided.
- Quantity
- 45 customers with affected configuration in US, 37 customers ROW.
- Distribution
- Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain.
- Lot, serial or model codes
- Coherence RT Therapist v2.1x - Part # 10652387; Coherence RT Therapist v2.2x - Part # 10652388.
- 510(k) numbers
- ["K060226","K072486","K993425"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- 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