Siemens Medical Solutions USA, Inc Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Assist part number 8151297.
Products Sold
Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297.
Siemens Medical Solutions USA, Inc is recalling Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Ex due to Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, att. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.
Recommended Action
Per FDA guidance
The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation. If you have any questions, call 1-925-602-8157.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026