Z-2812-2015Class II

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist...

Name: Z-2812-2015 ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-08-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-08-05 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The... on 2015-08-05. FDA classified it as Class II and gives the reason as "A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients". 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-2812-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Posted: 2015-09-24
Terminated: 2016-09-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues.
Quantity in commerce: 26
Distribution: Worldwide Distribution and US Nationwide
Product codes and lots: ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression 07360717 PRIMUS - K993425 PRIMUS Plus 04504200 Syngo RT Therapist - 08162815 serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2812-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2812-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)