Z-0437-2014Class II

SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam...

Name: Z-0437-2014 SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-10-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-10-23 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or... on 2013-10-23. FDA classified it as Class II and gives the reason as "A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0437-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Posted: 2013-12-03
Terminated: 2014-01-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent Medical Device Correction letter dated October 23, 2013 including the release of update instruction TH024/13/S to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.
Product codes and lots: Serial Numbers: 5281, 5385, 5445

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0437-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0437-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-03
Z-0438-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-03

Product code IYE

K060226Class IIOncor ExpressionSiemens Medical Solutions USA, Inc. / cleared 2006-03-15

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)