Z-0116-2009

Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1...

Name: Z-0116-2009 Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-07-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-07-04 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy... on 2008-07-04. The reason FDA records is "Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images". 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-0116-2009
Status: Terminated
Initiated: 2008-07-04
Posted: 2008-10-20
Terminated: 2010-12-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.
Root cause tag: software
FDA root cause: Software change control
Action: A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.
Quantity in commerce: 16
Distribution: Nationwide in LA, WI, DE, PA and OH, and internationally in Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium and France
Product codes and lots: All products with COHERENCE Therapist RTT4.1

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)