FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
- Recall number
- Z-0441-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
- Status
- Terminated
- Initiated
- 2021-12-09
- Posted
- not on file
- Terminated
- 2023-05-04
- Reason
- Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
- Root cause
- Other
- Action
- Siemens issued Urgent Medical Device Corrction Letter CSAN TH001/21/S on 12/09/2021 to inform them of the potential issue and associated risk. Acton to take: 1. Carefully verify all planned treatment parameters against those actually set during patient setup before treating a patient. 2. Choose one of the following workflow options: - Use absolute table positions. In this case, positioning on a different isocenter would not match the planned table values and the system would prompt an override request. This minimizes the risk of selecting a wrong site fraction group. Or - In the case of mulitple sites, select and download one site at a time from ARIA. In this case, RTT would only display one site. Or - Create a multiple isocenter plan in ARIA. RTT cross checks table positions and selected isocenter coordinates. Siemens also recommends consulting the your system s Instructions for Use, Chapter 3.3.4, One treatment plan divided into two plans . The workflow described in this section prevents the occurrence of the reported incident. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understood the content therein. Siemens Healthineers is not planning a correction for this (potential) issue. The intent of this Customer Safety Advisory Notification is to remind you of the importance to diligently verify the correct treatment parameters when multiple sites get loaded into the RT Therapist.
- Quantity
- 13 units
- Distribution
- US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
- Lot, serial or model codes
- Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911
- 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