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.
This recall has been terminated (originally issued January 30, 2009).
- Recall Initiated
- December 20, 2008
- Posted
- January 30, 2009
- Terminated
- December 9, 2010
- Recall Number
- Z-0949-2009
- Quantity
- 43 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.
Distribution
Nationwide and Worldwide
Lot / Code Info
All units of Part Number: 8139789
Root Cause
Device Design
Action Taken
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.
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