Z-0857-2009

Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67...

Name: Z-0857-2009 Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67...
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: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number... on 2008-10-23. The reason FDA records is "Under certain conditions, the flat panel may move unexpectedly and collide with the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0857-2009
Status: Terminated
Initiated: 2008-10-23
Posted: 2009-01-14
Terminated: 2010-12-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Under certain conditions, the flat panel may move unexpectedly and collide with the patient.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediately. The firm is tracking responses via return cards and completion protocol.
Quantity in commerce: 31 consignees have the configuration noted above.
Distribution: Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada.
Product codes and lots: Part # 8139789, with Syngo RT Therapist version 4.1 build 67

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)