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IMPORTANT FIELD SAFETY NOTICE
PRODUCT: Digital Accelerator
Date: 11-2012 FCO Ref: 200 01 103 068
Modification of the Synergy Base Drive Wheel Assembly
This Notice contains important information about the operation of your product. Elekta recommends that all
users of the product follow the instructions or recommendations in this Notice.
This Notice must be put in the Important Notice section of the applicable manual.
If you have any queries about this Notice, contact your local Elekta office.
Scope: Machine numbers 105345 to 151764 (inclusive), with XVI

This FCO supersedes Important Field Safety Notice 200 01 103 061.
Problem: In a small number of digital accelerators, the Gantry Base wheel bolts have become loose
and caused a malfunction.
There have been a small number of digital accelerators where the joint between the drive
gear and the gantry base drive wheel has become loose. This has lead to fatigue failure of
the securing bolts. These systems were all fitted with XVI and are therefore the subject of
this notice.
Clinical impact: There will be no clinical mistreatment as the gantry positioning encoder is separate to this
system.
If the bolts for all drive wheels fail during gantry movement while a patient is being treated
with a table position of 0º and at isocentric height, then there is no risk of collision with the
patient.
If the bolts for all drive wheels fail during gantry movement while a patient is being treated
o
with a table position other than 0 or other than isocentric height, then there is a remote
risk of collision with the patient.
Solution: An inspection procedure and modification kit is available and must be completed as soon
as possible. Refer to Important Field Safety Modification 200 02 103 067
Your local Elekta office will be in contact with you to arrange to carry out this
inspection/modification.
This Notice has been notified to the appropriate Regulatory Authority
FCO 200 01 103 068 VID: 1.0 Elekta Limited, Linac House, Fleming Way, Crawley, Page 1 of 3
West Sussex RH10 9RR, UK
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321
Copyright ©2011 Elekta AB. All rights reserved www.elekta.com DID: gPOL0007_1 VID: 01
Figure 1: Location of drive wheel and bolts
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321
FCO ACTION NOTIFICATION REPORT
<Give this Notice to the customer, and then complete and return this report to your local Elekta Office or Representative
for the Configuration Database.>
Classification: Important Field Safety Notice FCO Ref: 200 01 103 068
FCO
description:
Scope: Machine numbers 105345 to 151764 (inclusive), fitted with XVI
Hospital:
Device Serial No: Location or

(e.g. linac - if applicable) Site No:
Action on this unit/device was: (select one) Note: If you use a work-order in the CLM configuration
database, then you do not have to complete this
section. The work-order will be used to add the
Completed as per instructions on: <date day/month/year]> information to the system.
Not completed because: (give reasons)
Not completed because the unit/device is in storage (if applicable).
Refused by customer because: (give reasons)
Acknowledgement by customer:
This notification to be signed by the customer.
The REASON and PURPOSE of this notice has been explained.

Name: Title:
Signature: Date:
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321
IMPORTANT FIELD SAFETY MODIFICATION
PRODUCT: Digital Accelerator
Date: 11-2012 FCO Ref: 200 02 103 067
Relates to: 200 01 103 068
Scope: Machine numbers 105345 to 151764 (inclusive), with XVI
This FCO supersedes Important Field Safety Modification 200 02 103 053.
Description: This document provides instructions for adding friction shims and screw sleeves to
Synergy Gantry Base Drive Wheel Assemblies.
Technical reference: MH/EOS110570
Manpower: 2 engineers, 0.5 days
Tools & test equipment: Gantry Wheel Tool Kit – Part Number 1502421
6 Tonne Lifting Jack (Enerpac or similar) (supplied locally)
Loctite 243 (supplied locally)
Torque Wrench to 40Nm
6mm Hex Socket for Torque Wrench
Parts required: Gantry Drive Wheel Mod Kit – Part Number 1500653
__________________________________________________________________
Details:
Before you do this procedure, inspect the A-side rear gantry base wheel. If there is no paint in the area
indicated (as shown in the picture below), you do not need to do the modification.
If the surface is painted, obtain the parts listed above and do the instructions in the modification kit.
Elekta recommends that at least one Gantry Wheel Tool Kit is purchased by each affected Business Unit in
order to complete the modifications as quickly as possible.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321
Safety reference:
The following warnings and cautions are associated with this notice:
1. Do not let the full weight of the gantry drum sit on any lifting device. Suitable supports must be used at all
times.
2. Safety straps must be attached to the gantry drum during these procedures.
Procedure:
1 Read the instructions in the modification kit (ModKit) before you start to implement the change. Make sure
that all the parts on the dispatch list are delivered.
2 Use the drawing(s) supplied and/or the installation instructions, and follow the step by step instructions and
implement the modification.
3 When the modification is complete update the modification record label on the applicable assembly with
the ECO number in the Technical Reference Number, if applicable.
4 If applicable, put the modification instructions and the FCO in the service documentation for reference.
5 If required by local procedures, make sure that all paperwork is completed in full and sent to the local
Elekta Office and/or representative, to add to the Configuration Database.
6 Make sure that any parts to be returned to Elekta Limited are packaged correctly, and dispatched without
delay using a Returns Authorization (RA) number. An RA number is supplied by the Spares Department
on request.
NOTE: Parts that have come into contact with body fluids (for example, top of treatment table) or constitute a
radiation hazard must have a signed Declaration of Contamination Status included with the part BEFORE it
is returned.
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321
FCO ACTION NOTIFICATION REPORT
<Give this Notice to the customer, and then complete and return this report to your local Elekta Office or Representative for
the Configuration Database.>
Classification: Important Field Safety Modification FCO Ref: 200 02 103 067
FCO
description:
Scope: Machine numbers 105345 to 151764 (inclusive), fitted with XVI
Hospital:
Device Serial No: Location or

(eg linac - if applicable) Site No:
Action on this unit/device was: (select one) Note: If you use a work-order in the CLM configuration
database, then you do not have to complete this
section. The work-order will be used to add the
Completed as per instructions on: <date day/month/year]> information to the system.
Not completed because: (give reasons)
Not completed because the unit/device is in storage (if applicable).
Refused by customer because: (give reasons)
Acknowledgement / Acceptance / Refusal by customer:

This notification to be signed by the customer.
The REASON and PURPOSE of this modification has been explained.

Name: Title:
Signature: Date:
Acknowledgement by installing engineer:

This section is signed by the Elekta representative, for example, Installation Engineer, Service Engineer, Distributor, or
who installed the modification kit, for example, a hospital representative or system operator.
Name: Title:
Signature: Date:
Tel: +44 (0)1293 544422 Fax: +44 (0)1293 654321

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IMPORTANT FIELD SAFETY NOTICE

PRODUCT: Digital Accelerator

Date: 11-2012 FCO Ref: 200 01 103 068

Modification of the Synergy Base Drive Wheel Assembly

Scope: Machine numbers 105345 to 151764 (inclusive), with XVI

This Notice has been notified to the appropriate Regulatory Authority

This Notice has been notified to the appropriate Regulatory Authority

Scope: Machine numbers 105345 to 151764 (inclusive), fitted with XVI

Device Serial No: Location or

Not completed because: (give reasons)

Not completed because the unit/device is in storage (if applicable).

Refused by customer because: (give reasons)

The REASON and PURPOSE of this notice has been explained.

This Notice has been notified to the appropriate Regulatory Authority

PRODUCT: Digital Accelerator

Date: 11-2012 FCO Ref: 200 02 103 067

Modification of the Synergy Base Drive Wheel Assembly

Relates to: 200 01 103 068

Scope: Machine numbers 105345 to 151764 (inclusive), with XVI

Technical reference: MH/EOS110570

Manpower: 2 engineers, 0.5 days

Scope: Machine numbers 105345 to 151764 (inclusive), fitted with XVI

Device Serial No: Location or

Not completed because: (give reasons)

Not completed because the unit/device is in storage (if applicable).

Refused by customer because: (give reasons)

Acknowledgement / Acceptance / Refusal by customer:

The REASON and PURPOSE of this modification has been explained.

Acknowledgement by installing engineer:

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