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
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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