Field Corrective Action Reference: FCA-IMS-0044

This notice reference: 382-01-MON-023

(HPQC 7700)

URGENT IMPORTANT FIELD SAFETY NOTIFICATION

FCO: 382-01-MON-023, VID: 1.0 Page 1 of 4

Elekta Solutions AB Box 7593, Kungstensgatean 18 SE – 103 93 Stockholm Sweden +46 8587 254 00

Elekta, Inc. 1450 Beale Street, Suite

205 St. Charles, Missouri 63303

Tel: 314 993 0003 Toll Free: 800 878 4267

Confidential and Proprietary Information © Elekta Group 2023. All Rights Reserved QMS0433EN-07

www.elekta.com Elekta Care™ Community

Subject: Re-optimization, After Adding Contours Without Forced Density Outside the External Structure, May Result in Inaccurate Dose Presentation

Product: Monaco®

Scope: Monaco® customers who have created plans with Versions 5.11.xx using the specific workflow described below. Other Monaco® releases are not affected.

Notification Released: February 2023

UDI Reference: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01,

(01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03

Description of Problem: A sequence of steps performed by the user, consisting of an initial optimization, expansion of a structure or the creation of a new margin structure outside of the external contour and without forced density, change of the optimization criteria, and continuation of the optimization, may result in apertures that deliver doses on an incorrectly shifted position of the target – a geometrical miss. Moreover, after the final optimization, it is possible that the dose distribution in Monaco® looks like it is conforming to the target at the original location, as desired. However, if the plan is delivered to the patient, the delivered dose may be shifted and will not match the dose distribution calculated in Monaco®.

Details: The problem can be reproduced using the following workflow steps:

1. A plan is optimized. 2. A contoured region, without a forced density, is added to a structure set outside of the external

contour, causing the calculation extents to expand to cover the new structure. Monaco does not recognize that the dose calculation grid and the structure occupancy grids used by the optimizer should be reset.

3. Optimization criteria are modified, for example by changing the reference dose of a cost function or by adding / deleting a cost function that contains a reference dose while the optimization results are still in memory (i.e., the plan has not been unloaded since the previous optimization finished).

4. At this point, the calculation extents are expanded but the grid in the optimizer is not expanded to match the modified calculation extents.

5. Continue the optimization.

Field Corrective Action Reference: FCA-IMS-0044

This notice reference: 382-01-MON-023

(HPQC 7700)

URGENT IMPORTANT FIELD SAFETY NOTIFICATION

FCO: 382-01-MON-023, VID: 1.0 Page 2 of 4

Elekta Solutions AB Box 7593, Kungstensgatean 18 SE – 103 93 Stockholm Sweden +46 8587 254 00

Elekta, Inc. 1450 Beale Street, Suite

205 St. Charles, Missouri 63303

Tel: 314 993 0003 Toll Free: 800 878 4267

Confidential and Proprietary Information © Elekta Group 2023. All Rights Reserved QMS0433EN-07

www.elekta.com Elekta Care™ Community

This problem was identified when the above workflow was utilized with a margin to the external structure to evaluate for changes visible in the cone beam CT.

Once the plan is re-optimized (Step 5 above, Details), the target position within the optimizer will be shifted with respect to the calculated dose. Once the optimization is complete, the calculated dose may be shifted with respect to the MLC positions. If the plan is exported and delivered at this point, the delivered dose will be consistent with the shifted MLC shapes and will not reflect the dose displayed in Monaco®.

Clinical Impact: The clinical impact of such an error is directly affected by the size of the geometrical miss (shift), which can range from zero or negligible to a few centimeters, depending on how much the dose calculation extent is expanded after adding the contour outside the patient in (Step 2 above, Details).

A problematic plan will be identified if a dose recalculation is forced in Monaco® or by using a secondary dose calculation for quality assurance (QA). However, a measurement-based QA procedure, such as delivering the plan on a phantom and measuring the dose, will not identify a problematic plan as the dose delivered to the phantom will match the calculated QA plan dose.

Field Corrective Action Reference: FCA-IMS-0044

This notice reference: 382-01-MON-023

(HPQC 7700)

URGENT IMPORTANT FIELD SAFETY NOTIFICATION

FCO: 382-01-MON-023, VID: 1.0 Page 3 of 4

Elekta Solutions AB Box 7593, Kungstensgatean 18 SE – 103 93 Stockholm Sweden +46 8587 254 00

Elekta, Inc. 1450 Beale Street, Suite

205 St. Charles, Missouri 63303

Tel: 314 993 0003 Toll Free: 800 878 4267

Confidential and Proprietary Information © Elekta Group 2023. All Rights Reserved QMS0433EN-07

www.elekta.com Elekta Care™ Community

Recommended User Action: The problem will not occur if the added contour outside the external contour has an assigned density. If you believe that patient plans at your site could have been affected by this workflow, please contact Elekta Care Support if help is needed to identify those patients.

This document contains important information for the continued safe and

proper use of your equipment.  Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is

closed.  Advise the appropriate personnel, working with this product, on the content of this letter.

Elekta Corrective Actions:

The issue has been fixed in Monaco® releases 5.40 and above. If you are running a 5.11.xx version, please

contact Elekta Care Support to upgrade to a newer software version.

This notice has been submitted to the appropriate Regulatory Authorities.

We sincerely apologize for any inconvenience this action may cause and thank you in advance for your

cooperation.

Field Corrective Action Reference: FCA-IMS-0044

This notice reference: 382-01-MON-023

(HPQC 7700)

URGENT IMPORTANT FIELD SAFETY NOTIFICATION

FCO: 382-01-MON-023, VID: 1.0 Page 4 of 4

Elekta Solutions AB Box 7593, Kungstensgatean 18 SE – 103 93 Stockholm Sweden +46 8587 254 00

Elekta, Inc. 1450 Beale Street, Suite

205 St. Charles, Missouri 63303

Tel: 314 993 0003 Toll Free: 800 878 4267

Confidential and Proprietary Information © Elekta Group 2023. All Rights Reserved QMS0433EN-07

www.elekta.com Elekta Care™ Community

Acknowledgement Form

In order to meet regulatory requirements, you are required to either acknowledge receipt of this notification via

the Elekta Care™ Community or complete this form and return it to Elekta immediately upon receipt, but no

later than within 30 days.

Classification: Important Field Safety Notification FCO Reference Number:

382-01-MON-023

Description: Re-optimization, After Adding Contours Without Forced Density Outside the External Structure, May Result in Inaccurate Dose Presentation

Hospital:

Device Serial No(s): (if applicable)

Location or Site:

I acknowledge that I have read and understood this Notice and accept the implementation of any given recommendation.

Name: Title:

Customer Signature:

Date:

New installation confirmation to be signed by the installing Elekta engineer or a Representative employee, when the installed product has a physical IFU/manual:

I acknowledge that the customer has been informed on the content of this notice and that it has been inserted into the applicable copy of the User Manual, or added on record with the applicable User Manual:

Name: Title:

Signature: Date:

Signature Manifest

Document Number: E065103 Revision: 01

Title: 382-01-MON-023

Effective Date: 15 Feb 2023

All dates and times are in Netherlands.

382-01-MON-023

Document Approval

Name/Signature Title Date Meaning/Reason

Colleen Heelan (USHEECOL) 13 Feb 2023, 04:26:03 PM Approved

Randy Larson (USLARRAN) 13 Feb 2023, 05:14:55 PM Approved

Luis Avila (LAVIE08463) 14 Feb 2023, 05:21:02 AM Approved

Jack Luo (USLUOJAC) 14 Feb 2023, 06:56:41 AM Approved

Anju Kurian (AKURE09085) 15 Feb 2023, 02:30:50 PM Approved

Nicholas Schupp (USSCHNIC) 15 Feb 2023, 05:08:25 PM Approved

RSL-P-RS FSN Class III 109886 EN Field Safety Notice, Medical Device Correction #109886

RaySearch Laboratories AB (publ), P.O. Box 45169 SE-104 30 Stockholm Sweden, Visitors: Eugeniavägen 18C Phone +46 8 510 530 00 www.raysearchlabs.com Page 1 (5)

Field Safety Notice, Medical Device Correction #109886

RayStation, RayPlan 9A, 9B, 10A, 10B, 11A, 11B and 12A including

service packs To determine if your version is affected, see build numbers

listed in PRODUCT NAME AND VERSION below 16th February, 2023

RSL-P-RS FSN Class III 109886

Issue This notice concerns issues with DICOM export from the Virtual Simulation module and issues with import

of Virtual Simulation plans in RayStation, RayPlan 9A, 9B, 10A, 10B, 11A, 11B and 12A including service

packs.

The user must be aware of the following information to avoid incorrect treatment delivery.

Intended audience This notice is directed to all users of RayStation who use the Virtual Simulation module.

Product Name and Version The products affected by this notice are sold under the trade names RayStation, RayPlan 9A, 9B, 10A,

10B, 11A, 11B and 12A including service packs. To determine if the version you are using is affected, open

the About RayStation dialog in the RayStation application and check if the build number reported there is

‘9.0.0’, ‘9.0.1’, ‘9.1.0’, ‘9.2.0’, ‘10.0.0’, ‘10.0.1’, ‘10.0.2’, ‘10.1.0’, ‘10.1.1’, ‘11.0.0’, ‘11.0.1’, ‘11.0.3’, ‘11.0.4’,

‘12.0.0’, ‘12.1.0’, ‘12.1.1’, ‘12.0.3’, ‘12.1.2’, ‘12.0.4’, ‘12.1.3’, ‘13.0.0’, or ‘13.1.0’. If so, this notice applies to

your version.

The single registration number (SRN) of the manufacturer: SE-MF-000001908

Product name (build number) UDI-DI

RayStation 9A (9.0.0.113) 0735000201017420190612

RayStation 9A SP1 (9.0.1.142) 0735000201048820220420

RayStation 9B (9.1.0.933) 0735000201026620191220

RayStation 9B SP1 (9.2.0.483) 0735000201029720200310

RayStation 10A (10.0.0.1154) 0735000201030320200526

RayStation 10A SP1 (10.0.1.52) 0735000201036520200526

RayStation 10A SP2 (10.0.2.10) 0735000201065520220608

RayStation 10B (10.1.0.613) 0735000201031020201216

RayStation 10B SP1 (10.1.1.54) 0735000201047120220128

RayStation 11A (11.0.0.951) 0735000201038920210518

RSL-P-RS FSN Class III 109886 EN Field Safety Notice, Medical Device Correction #109886

RaySearch Laboratories AB (publ), P.O. Box 45169 SE-104 30 Stockholm Sweden, Visitors: Eugeniavägen 18C Phone +46 8 510 530 00 www.raysearchlabs.com Page 2 (5)

RayStation 11A SP1 (11.0.1.29) 0735000201043320210610

RayStation 11A SP2 (11.0.3.116) 0735000201044020210916

RayStation 11A SP3 (11.0.4.15) 0735000201063120220616

RayStation 11B (12.0.0.932) 0735000201042620211208

RayStation 11B SP1 (12.1.0.1221) 0735000201049520220312

RayStation 11B SPC1 (12.1.1.41) 0735000201058720220330

RayStation 11B SP2 (12.0.3.68) 0735000201050120220422

RayStation 11B SPC2 (12.1.2.91) 0735000201061720220517

RayStation 11B SP3 (12.0.4.12) 0735000201060020220620

RayStation 11B SPC3 (12.1.3.162) 0735000201066220221003

RayStation 12A (13.0.0.1547) 0735000201054920220616

RayStation 12A SP1 (13.1.0.144) 0735000201067920221007

Description Export It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct

in the user interface but if the plan is DICOM exported by using the “VSIM Export” button (see Figure 1

below), the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute

Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

It is also possible to select wedges and cones in the Virtual Simulation module. Any selected wedges or

cones will be ignored at export if using the “VSIM Export” button.

Figure 1. The “VSIM Export” button.

These issues only affect DICOM export from the Virtual Simulation module. If the Virtual Simulation plan is

exported from another RayStation module or from the RayStation menu (see Figure 2 below), the DICOM

attribute Beam Limiting Device Angle (300A,0120) will be correct and any wedges and/or cones will be

included.

Figure 2. The RayStation menu button.

Import If an RT Plan is imported into RayStation either without defined MU values or including a block with missing

information, it will be imported as a Virtual Simulation plan in RayStation. The conditions that need to be

fulfilled for this to happen are:

RSL-P-RS FSN Class III 109886 EN Field Safety Notice, Medical Device Correction #109886

RaySearch Laboratories AB (publ), P.O. Box 45169 SE-104 30 Stockholm Sweden, Visitors: Eugeniavägen 18C Phone +46 8 510 530 00 www.raysearchlabs.com Page 3 (5)

1. It needs to be a RT Plan with SOP Class UID (0008,0016) “1.2.840.10008.5.1.4.1.1.481.5”

2. All beams need to have Radiation Type (300A,00C6) “PHOTON” and Beam Type (300A,00C4)

“STATIC”

3. One or more of the following things needs to be true:

a. Number of Blocks (300A,00F0) is larger than 0 and Total Block Tray Factor (300A,00F2)

is either missing or outside the interval [0.5, 1.0]

b. There are more than 2 items in the Block Sequence (300A,00F4)

c. There is at least one block with a Block Divergence (300A,00FA) that is not “PRESENT”

d. There is at least one block with a Block Transmission (300A,0102) that is either missing

or outside the range [0.0, 0.2]

e. There is at least one block without a Block Tray ID (300A,00F5)

f. There are two blocks with the same Block Type (300A,00F8)

g. There is a block with Total Block Tray Factor (300A,00F2) that does not match the block

tray transmission definitions in RayPhysics

h. There is at least one control point without a Cumulative Meterset Weight (300A,0134)

value specified

If a plan is imported as a Virtual Simulation plan, the user is notified with an import warning which is also

stored in the import log (see Figure 3 for an example).

Figure 3. Example of warning displayed when Virtual Simulation import occurs.

If this type of import is triggered there are some attributes that would typically be imported that are

ignored. This includes, but is not limited to:

• Table Top Pitch Angle (300A,0140) – will be set to 0 by the VSIM import

• Table Top Roll Angle (300A,0144) – will be set to 0 by the VSIM import

• Any boli referenced by beams will not be set on the imported beam for an imported virtual

simulation plan

• Any wedges included in the imported RT Plan will not be imported

• Any cones included in the imported RT Plan will not be imported

• If the RT Plan contains multiple control points with different MLC positions only the positions of the

first control point will be converted into a virtual aperture block

There are several validations not performed for a VSIM import, that would typically generate warnings or

block the import completely.

RSL-P-RS FSN Class III 109886 EN Field Safety Notice, Medical Device Correction #109886

RaySearch Laboratories AB (publ), P.O. Box 45169 SE-104 30 Stockholm Sweden, Visitors: Eugeniavägen 18C Phone +46 8 510 530 00 www.raysearchlabs.com Page 4 (5)

If dose is calculated for a plan imported as a Virtual Simulation plan, it will correspond to the plan in

RayStation, but may not correspond to the original plan.

Actions to be taken by the user • Be aware that an RT plan exported by using the “VSIM Export” button will always have the DICOM

attribute Beam Limiting Device Angle (300A,0120) set to zero.

• Be aware that an RT plan exported by using the “VSIM Export” button will always have the DICOM

attribute Number of Wedges (300A,00D0) set to zero and no wedge information will be exported.

• Be aware that an RT plan exported by using the “VSIM Export” button will never include the DICOM

attribute Applicator Sequence (300A,0107) and no cone information will be exported.

• Do not use or export Virtual Simulation plans with non-zero collimator angle, wedges or cones

using the “VSIM Export” button.

• Be aware that a plan imported as a Virtual Simulation plan may not contain all intended

information and that some attributes affecting dose may be different from the original plan.

• Always perform dose computation for imported Virtual Simulation plans before export. Do not use

the “VSIM Export” for export of such plans.

• Educate planning staff and all users about this workaround.

• Inspect your product and identify all installed units with the above software version number(s).

• Confirm you have read and understood this notice by replying to the notification email.

Solution This issue will be resolved in the next version of RayStation, scheduled for market release in June 2023

(subject to market clearance in some markets). If customers wish to continue using versions of RayStation

affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can

choose to upgrade to the new version once it becomes available for clinical use.

Transmission of this Notice This notice needs to be passed on to all those who need to be aware within your organization. Maintain

awareness of this notice as long as any affected version is in use.

Thank you for your cooperation, and we apologize for any inconvenience.

For regulatory information, please contact [email protected].

RaySearch will notify the appropriate regulatory agencies about this Field Safety Notice.

CONFIRMATION OF RECEIPT

RSL-P-RS FSN Class III 109886 EN Field Safety Notice, Medical Device Correction #109886

RaySearch Laboratories AB (publ), P.O. Box 45169 SE-104 30 Stockholm Sweden, Visitors: Eugeniavägen 18C Phone +46 8 510 530 00 www.raysearchlabs.com Page 5 (5)

Please confIrm that you have received this FSN

Reply to the same email address that sent you this notice, stating you have read and understood it.

Alternatively, you can email or phone your local support to acknowledge this notice.

If you want to attach a signed reply form to the email, please fill in the below. You can also fax this form

to Fax: +1-631-828-2137 (US only).

From: _____________________________________________ (name of institution)

Contact person: _____________________________________________ (please print)

Telephone no: _____________________________________________

Email: _____________________________________________

I have read and understood the notice.

Comments (optional):

______________________________________________________

______________________________________________________