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.
FDA Recall Z-0949-2009 · Posted 2009-01-30
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-12-20
Date Terminated2010-12-09
Product Quantity43 units
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Nationwide and Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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