FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
- Recall number
- Z-3003-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
- Status
- Terminated
- Initiated
- 2011-06-03
- Posted
- 2011-08-11
- Terminated
- 2012-02-17
- Reason
- A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.
- Root cause
- Software design
- Action
- Siemens sent an "Urgent: Medical Device Correction/ Customer Safety Advisory Notice" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should remain.
- Quantity
- 223 active devices
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and United Kingdom.
- Lot, serial or model codes
- Therapist Express Basic, Part Number 08151289; Therapist Express Assist, Part Number 08151297; syngo RT Therapist Assist, Part Number 08162807; syngo RT Therapist, Part Number 08162815; syngo RT Therapist Connect/MOSIAQ OIS, Part Number 08168754.
- 510(k) numbers
- ["K060226","K072485","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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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