URGENT FIELD SAFETY NOTICE
Contents
1. Page 1 of 4 URGENT FIELD SAFETY NOTICE Date 18 November 2014 Attention TomoTherapy System Medical Physicist Affected Product Software versions 2 0 1 2 0 2 2 0 3 Hi Art 5 0 1 5 0 2 5 0 3 Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs This may result in an incorrect jaw position during treatment without generating a system interruption Please review the following information with all applicable members of your staff Description of the Issue On rare occasions a jaw communication issue may occur and the jaws will not perform any further planned movement If this occurs prior to beam on during a delivery procedure the jaw monitoring system will interlock appropriately However if this occurs at the beginning of beam on software anomaly 54148 can then cause the jaw monitoring system to stop monitoring the jaw position The jaws will then remain stationary for the remainder of the procedure This issue is unlikely to have a dosimetric impact for procedures using static jaws unless a separate additional error occurred during beam on Procedures using static jaws will start at the correct position and then remain stationary For TomoEDGE Dynamic Jaw procedures the jaws will remain at the position specified at the beginning of the procedure and the procedure will appear to finish normally although the jaw2. my staff Name print ________________________________________________________ Signature ________________________________________________________ Hospital Name ________________________________________________________ Date ___________________ Please keep this Field Safety Notice regarding Dynamic Jaw Field Widths during Treatment with your User Manual Send to Accuray International REGULATORY AFFAIRS amp QUALITY ASSURANCE EIMEA e mail EIMEA RAQA accuray com subject line FSCA 5 0 4
3. e jaws are more likely to start at a wider opening and fail to close properly at the end of the delivery potentially causing extra radiation to be delivered to the area inferior to the target region Instead contact Accuray Customer Support Page 3 of 4 Final Resolution A software fix to the monitoring system has been implemented in version 2 0 4 5 0 4 software You will be contacted by Accuray Customer Support to schedule a software upgrade to your system For more information or to ask any questions about this notification please contact Accuray Customer Support at 1 877 668 8667 or visit the Accuray Technical Solutions Center at www accuray com gt Services amp Support or call North America 1 877 668 8667 Europe 800 4141 9595 Hong Kong 852 2247 8688 Japan 81 3 6269 9556 Please complete the attached acknowledgment for this notification and return to Accuray Regulatory Affairs Sincerely Joy M Sacmar Vice President Regulatory Affairs Page 4 of 4 ACKNOWLEDGMENT FORM URGENT FIELD SAFETY NOTICE TomoTherapy Systems with software versions 2 0 1 2 0 2 2 0 3 Hi Art 5 0 1 5 0 2 5 0 3 I acknowledge that I have received the following document from Accuray Urgent Field Safety Notice Concerning Dynamic Jaw Field Widths during Treatment I confirm that I understand the content of this Field Safety Advisory Notification dated November 18 2014 and have distributed the information to all applicable members of
4. s remain stationary for the remainder of the procedure By reviewing machine logs the probability of the jaws remaining at a static position throughout the remainder of a TomoEDGE Dynamic Jaw Procedure has been determined to be approximately 0 03 3 in 10 000 Example For a dynamic jaw procedure the field width will start at 1 05cm In normal operation this field width will increase until the maximum planned field width has been achieved In the event that the issue above occurs the field width will stay at 1 05cm for the remainder of the procedure with the jaws in their maximally asymmetric position as shown in the screenshot from the Operator Station in Figure 1 below Page 2 of 4 Figure 1 Screenshot from the Operator Station showing the asymmetric 1 05cm beam that would be expected at the superior edge of the target If the issue described in this notice occurs this field will not change during treatment Safety Instructions For TomoEDGE Dynamic Jaw procedures either Replan these procedures using the static jaw delivery mode or At the Operator Station see Figure 1 monitor the Width for the IEC Y Field cm at the beginning of these procedures to ensure that it increases over time If it does not increase stop treatment and contact Accuray Customer Support for assistance We recommend you do not deliver TomoEDGE Dynamic Jaw completion procedures If this error occurs during a completion procedure th
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