FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.
- Recall number
- Z-2977-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.
- Status
- Terminated
- Initiated
- 2011-06-03
- Posted
- 2011-08-10
- Terminated
- 2012-03-30
- Reason
- A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.
- Root cause
- Software design
- Action
- Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides preventive measure instructions for customers to use until an update for the system is available.
- Quantity
- 121 devices
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, and United Kingdom.
- Lot, serial or model codes
- The ARTISTE RT Therapist v4.2 and Oncologist v4.2 is used on the following: syngo RT Oncologist Part # 10652131; Therapist Express Basic, Part # 08151289; syngo RT Therapist, Part # 08162815; syngo RT Therapist Connect / MOSAIQ OSI, part # 08168754.
- 510(k) numbers
- ["K080906"]
- 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