Siemens Medical Solutions USA, Inc Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, 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 Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA Medical charged-particle radiation therapy system.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
All units of Part Number: 8139789
Products Sold
All units of Part Number: 8139789
Siemens Medical Solutions USA, Inc is recalling Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by due to The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.
Recommended Action
Per FDA guidance
On 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information.
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