Z-2174-2014Class II

Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment...

Name: Z-2174-2014 Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-05-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-05-28 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option on 2014-05-28. FDA classified it as Class II and gives the reason as "A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2174-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-28
Posted: 2014-08-10
Terminated: 2015-07-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
FDA root cause: Use error
Action: An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
Quantity in commerce: 160
Distribution: Nationwide and ROW, including Canada and Mexico.
Product codes and lots: material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2174-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2174-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-10

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)