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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm March 20, 2019
Create Date April 19, 2019
Recall Status1 Terminated 3 on June 18, 2020
Recall Number Z-1204-2019
Recall Event ID 82605
510(K)Number K072485  K993425  K060226  K121295  K031764  
Product Classification Accelerator, Linear, Medical - Product Code IYE
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.
Code Information 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
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer 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 Determined
Cause 2		 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 in Commerce 120 US units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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