Siemens Medical Solutions USA, Inc Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
All products with COHERENCE Therapist RTT4.1
Products Sold
All products with COHERENCE Therapist RTT4.1
Siemens Medical Solutions USA, Inc is recalling Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist due to Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be over. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.
Recommended Action
Per FDA guidance
A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.
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