Z-2404-2011

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators...

Name: Z-2404-2011 ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators...
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-04-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-04-15 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR... on 2011-04-15. The reason FDA records is "Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2404-2011
Status: Terminated
Initiated: 2011-04-15
Posted: 2011-06-02
Terminated: 2012-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment.
FDA root cause: Other
Action: Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to perform an "in session resumption of the beam by selecting 'abort' at the syngo RT Therapist and then re-selecting the beam again for the remaining delivery. In this case, the beam will be re-loaded with the originally prescribed leaf positions. Please consider the already delivered dose for resumption. Customers were asked to include the Customer Advisory Notice in their LINAC System Owner Manual in chapter 'Safety Advisory Letters' where it should remain until the measures defined above were performed. Customers were asked to inform all affected personnel immediately.
Quantity in commerce: 221 active devices
Distribution: Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.
Product codes and lots: Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472 ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717

Product code IYE

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)