Siemens Medical Solutions USA, Inc ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
All Product with Part Number 8139789 (RT Therapists are part of the system).
Products Sold
All Product with Part Number 8139789 (RT Therapists are part of the system).
Siemens Medical Solutions USA, Inc is recalling ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) o due to Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
Recommended Action
Per FDA guidance
Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 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 noticeDistribution
As reported by FDA
FL, MA, MI, NE, NJ, OH, PA, UT
Page updated: Jan 10, 2026