Z-0927-2009

Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by...

Name: Z-0927-2009 Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-10-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-10-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems... on 2008-10-23. The reason FDA records is "If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0927-2009
Status: Terminated
Initiated: 2008-10-23
Posted: 2009-01-29
Terminated: 2010-12-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone.
Quantity in commerce: 36 units
Distribution: Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.
Product codes and lots: Part Number 8139789, Serial Numbers: 5190, 5350, 5355, 5364, 5367, 5374, 5377, 5398, 5405, 5410, 5419, 5424, 5165, 5166, 5202, 5238, 5298, 5306, 5342, 5352, 5365, 5366, 5373, 5378, 5379, 5380, 5397, 5399, 5400, 5401, 5402, 5409, 5414, 5416, 5423 and 5425.

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)