Possible risk of a collision when you use XVI

and an external beam limiting device

Product: XVI

Date: May 2014

FCO: 200 01 507 086
We are providing the information in this Notice to notify you of an important safety issue that may
exist on your equipment, and to inform you of any actions needed to safeguard both your staff and
your patients. We ask that you please read and understand the content of this notice and
implement any recommendations provided.
We also need you to acknowledge and accept this FCO by signing and returning the statement on
the FCO Action Notification Report.
We advise you to insert this Notice in the applicable copy of the User Manual.

Possible risk of a collision when you use XVI and an

external beam limiting device

Product: XVI
Date: May 2014
FCO: 200 01 507 086

Scope: XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1

Description: This notice supersedes IUN 200 03 507 056/057 and IFSN 200 01 507 081.
XVI can incorrectly calculate the target position of the treatment table,
because of an error that does not occur very frequently. This is the
sequence of events when this error occurs:
 You do an online VolumeView™ acquisition and registration.
 You accept the registration and the Table Move Assistant dialog box
appears.

Two different scenarios can result from the same error.

Scenario 1:

This Notice has been notified to the appropriate Regulatory Authorities

FCO: 200 01 507 086 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Manor Page 2 of 7
Royal, Crawley, West Sussex. RH10 9RR.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

Copyright © 2013 Elekta AB. All rights reserved www.elekta.com gPOL0007-1 VID:2.0
 Figure 1: Table Move Assistant dialog box showing blank Relative Actual values

Figure 2: XVI incorrectly shows the Actual values as zero

 The Relative Actual column or the Absolute Actual of the Table Move
Assistant dialog box incorrectly appears blank.
 When this occurs, XVI does not read the Absolute Actual position of
the treatment table. This causes XVI to calculate the treatment table
moves from the zero position of the treatment table
(+0.0, +0.0, +0.0).
 If the Relative Set values are less than or equal to 2 cm, you can do
remote automatic table movement (RATM) from the function keypad
(FKP).
 When you press the Table ASU (automatic setup) buttons, the
treatment table moves to a position that was incorrectly calculated
from XVI.

This Notice has been notified to the appropriate Regulatory Authorities

FCO: 200 01 507 086 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Manor Page 3 of 7
Royal, Crawley, West Sussex. RH10 9RR.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

Copyright © 2013 Elekta AB. All rights reserved www.elekta.com gPOL0007-1 VID:2.0
 Scenario 2:

Figure 3: Example of Correct Actual position shown on Receive External Prescription

screen, incorrect Absolute Actual value on XVI Table Move Assistant.

 The Absolute Actual column of the Table Move Assistant dialog box
contains values which appear correct. However, this data is
inaccurate.
 If the Relative Set values are less than or equal to 2 cm, you can do
remote automatic table movement (RATM) from the function keypad
(FKP).
 When this occurs XVI does not receive Absolute Actual positions of
the treatment table. This causes XVI to incorrectly calculate the
target treatment table position.
 When you press the Table ASU (automatic setup) buttons, the
treatment table moves to the incorrect position.

This Notice has been notified to the appropriate Regulatory Authorities

FCO: 200 01 507 086 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Manor Page 4 of 7
Royal, Crawley, West Sussex. RH10 9RR.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

Copyright © 2013 Elekta AB. All rights reserved www.elekta.com gPOL0007-1 VID:2.0
 Clinical impact: Collision Risk

WARNING
Make sure that the gantry and treatment table movements are in view
at all times when you do ASU. If you ignore this warning, it can cause
fatal injury and clinical mistreatment.

If you do not monitor the patient and treatment table movements, and you
keep the Table ASU buttons pressed, the treatment table continues to
move. It only stops when a touchguard activates. Therefore, this error can
cause a collision between the patient and an external beam limiting device
(BLD) if:
 The external BLD does not operate with the touchguard attached.
 The external BLD extends out more than the touchguard.
If this error occurs with an external BLD attached to the digital accelerator,
you can cause fatal injury to the patient.

Clinical mistreatment
Scenario 1:
When the error occurs, it is not possible to get the Table Move Assistant
values in tolerance. Therefore, it is not possible to deliver treatment to a
patient in the incorrect position.

Scenario 2:
There is no potential for clinical mistreatment if the Relative Set is more than
0.1 cm. See Figure 3.

This Notice has been notified to the appropriate Regulatory Authorities

FCO: 200 01 507 086 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Manor Page 5 of 7
Royal, Crawley, West Sussex. RH10 9RR.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

Copyright © 2013 Elekta AB. All rights reserved www.elekta.com gPOL0007-1 VID:2.0
 Solution: Monitor the Relative Actual and Absolute Actual columns of the Table Move
Assistant dialog box, if these values are blank do not press the Table ASU
buttons on the FKP.
Or
If you see a movement larger than the Relative Actual and the Absolute
Actual does not update, follow this procedure to correct the error.

To correct the error:

1. Close the XVI program.
2. Shutdown and restart the XVI control system.
3. Put the patient in their initial setup position.
4. Acquire the VolumeView™ again, and continue the usual workflow.

When you do VolumeView™ acquisitions with an external BLD attached,

make sure that the stop angle of the VolumeView™ parameters is in the
lower half of the gantry rotation. This decreases the risk of a collision with
the patient.

A later software release of XVI will be supplied free of charge which gives a
solution to this problem.
Technical Reference: CLM 01690462, CLM01795287
Contact: If you have any queries about this Notice, contact your local Elekta office.

Safety reference
The following warnings and cautions are associated with this notice:

WARNING
Make sure that the gantry and treatment table movements are in view at all times
when you do ASU. If you ignore this warning, it can cause fatal injury and clinical
mistreatment.

This Notice has been notified to the appropriate Regulatory Authorities

FCO: 200 01 507 086 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Manor Page 6 of 7
Royal, Crawley, West Sussex. RH10 9RR.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

Copyright © 2013 Elekta AB. All rights reserved www.elekta.com gPOL0007-1 VID:2.0
Please complete the details below and sign the appropriate acknowledgement section:
 Existing installations; Acknowledgement by the customer
 New installations: New installation confirmation by the installing Elekta or Representative employee
Please return this report to your local Elekta Office or Representative, as soon as possible and within 30 days at the latest.

*The information in this FCO has been provided to address a safety issue and therefore the customer is expected
to acknowledge and accept the recommendations given, and ensure they are implemented. By refusing to
implement the recommendations, the customer assumes full responsibility and liability for all matters (including
costs, losses, claims, and expenses) resulting, whether directly or indirectly from not implementing such
recommendations. Further the customer will hold Elekta harmless from all matters (including costs, losses, claims
and expenses) resulting, whether directly or indirectly from not implementing such recommendations.
Failure to sign and return the acknowledgement may affect any follow-up actions necessary for us to take, and
may require Elekta to report to the Regulatory Authorities in your country.

Classification: Important Field Safety Notice FCO Ref: 200 01 507 086
FCO
Possible risk of a collision when you use XVI and an external beam limiting device
description:
Scope: XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1

Hospital:

Device Serial No: Location or

(e.g. linac - if applicable) Site No:

*
Acknowledgement by customer :
This notification to be signed by the customer
I acknowledge that I have read and understood this Notice and accept implementation of any given
recommendations:
Name: Title:

Signature: Date:

New installation confirmation:

This notification to be signed by the installing Elekta or Representative employee
Name: Title:

Signature: Date:

This Notice has been notified to the appropriate Regulatory Authorities

FCO: 200 01 507 086 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Manor Page 7 of 7
Royal, Crawley, West Sussex. RH10 9RR.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

Copyright © 2013 Elekta AB. All rights reserved www.elekta.com gPOL0007-1 VID:2.0