Z-0949-2009

Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens...

Name: Z-0949-2009 Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-12-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-12-20 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord... on 2008-12-20. The reason FDA records is "The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0949-2009
Status: Terminated
Initiated: 2008-12-20
Posted: 2009-01-30
Terminated: 2010-12-09
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 43 units
Distribution: Nationwide and Worldwide
Product codes and lots: All units of Part Number: 8139789

Product code IYE

K072485Class IIArtiste Mv SaSiemens Medical Solutions USA, Inc. / cleared 2007-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)