—#172025

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764, K060226, K072485, K121295, K993425
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Use error

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-03-20
Terminated: 2020-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.