Z-1888-2009

ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT...

Name: Z-1888-2009 ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-04-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-04-09 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with... on 2009-04-09. The reason FDA records is "Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment". 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-1888-2009
Status: Terminated
Initiated: 2009-04-09
Posted: 2009-09-24
Terminated: 2011-04-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 1-925-602-8157.
Quantity in commerce: 53 units
Distribution: Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.
Product codes and lots: All Product with Part Number 8139789 (RT Therapists are part of the system).

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)