Z-1204-2019Class II

Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI...

Name: Z-1204-2019 Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI...
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-03-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-03-20 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR... on 2019-03-20. FDA classified it as Class II and gives the reason as "Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1204-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Posted: 2019-04-19
Terminated: 2020-06-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from software version 9.2.400 and higher; and Control Console from software version 11.0.400 and higher.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
FDA root cause: Use error
Action: Siemens Healthcare issued CUSTOMER SAFETY ADVISORY NOTICE to accounts via electronic mail addresses and/or USPS certified mail on March 20. Letter identifies the issue , action to take: due to potential for collisions of the LINAC equipment with patients, Siemens Healthcare GmbH advises customers to not to disable or bypass the AMP function. Customers who decide to disable or bypass the AMP function, do so at their own responsibility, duly weighing patient benefit and risk. Disabling or bypassing for reasons of comfort is not advisable. Notify and instruct accordingly all the staff at your organization who need to be aware of this notice. In addition, if you may have further distributed this product, please identify your customers and notify them. Only in the event you choose to disable or bypass the AMP Function, Siemens requests that you carefully read and complete the following form. Please sign, scan, and email the completed form mail to:[email protected]
Quantity in commerce: 120 US units
Distribution: Nationwide
Product codes and lots: SIEMENS Digital Linear Accelerators of type ARTISTE", ONCOR" and PRIMUS" running: - Control Console from software version 13.0.302 and higher - Control Console from software version 9.2.400 and higher - Controle Console from software version 11.0.400 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1204-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1204-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-19

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)