Z-1652-2014Class II

Siemens Linear Accelerator (LINAC) models

Name: Z-1652-2014 Siemens Linear Accelerator (LINAC) models
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-04-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-04-01 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer on 2014-04-01. FDA classified it as Class II and gives the reason as "Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models". 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-1652-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Posted: 2014-05-23
Terminated: 2015-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Siemen sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Elekta representative.
Quantity in commerce: 9
Distribution: US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Product codes and lots: material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1652-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1652-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23

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