FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-1204-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-03-20
- Posted
- not on file
- Terminated
- 2020-06-18
- Reason
- 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.
- 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:csslmro.team@siemens-healthineers.com
- Quantity
- 120 US units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K031764","K060226","K072485","K121295","K993425"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28