URGENT – Field Safety Notice
Contents
1. e Please review the following information with all members of your staff who need to be aware of the contents of this communication It is important to understand the implications of this communication e Total impact to patient throughput and technologist workflow will vary per department Careful consideration must be taken in scheduling and desired image results must be understood regarding the limitations of NON AC amp NON LOC SPECT acquisitions NOTE XCT is available only for Nuclear Medicine SPECT studies KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice pD E l LI DS Philips Healthcare Advanced Molecular Imaging 7 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction e XCT Quality Assurance QA phantom studies as defined in the BrightView XCT User s Manual are affected e Collimator exchange functions as defined in the BrightView XCT User s2. FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction FIELD SAFETY NOTICE 88200490 CUSTOMER RESPONSE FORM HOSPITAL CENTER NAME ADDRESS CITY STATE PROVINCE ZIP CODE SYSTEM NAME SYSTEM SERIAL NUMBER DEPARTMENT CONTACT NAME DEPARTMENT CONTACT PHONE NUMBER SYSTEM STILL IN USE yes no e have received read and understand the content within the Field Safety Notice FSN 88200490 and Addendum ADDENDUM INSTRUCTIONS TO CONTINUE LIMITED USE e acknowledge Philips Healthcare s information and instructions in the Addendum INSTRUCTIONS TO CONTINUE LIMITED USE for the continued use of the system until a Philips Healthcare Representative conducts the appropriate field safety correction NAME PRINT TITLE PRINT SIGNATURE DATE IMPORTANT Please complete this Field Safety Notice 88200490 Customer Response Form IMPORTANT For United States Return the signed and dated response form WITHIN 10 DAYS OF RECEIPT via fax to number 1440 483 2950 or email to CTINM QARA philips com For other countries please follow your local office contact information Complete this form regardless of whether your system is still in use at your facility PHILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in p
3. this issue please contact your local Philips Healthcare representative For North America and Canada contact the Customer Care Solutions Center 1 800 722 9377 follow the prompts This notice has been reported to the appropriate Regulatory Agencies Sincerely Scott Christiansen Director of Quality and Regulatory PHILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice pD H l LI DS Philips Healthcare Advanced Molecular Imaging 2 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction AFFECTED PRODUCTS e BrightView XCT e BrightView X upgraded with the XCT Flat Panel Detector FPD PROBLEM DESCRIPTION Philips received a report from the field that the FPD failed to remain securely locked in the deployed position During a daily XCT Quality Assurance phantom scan for image quality and Hounsfield Unit HU linearity an operator experienced resista
4. your signed and dated response form WITHIN 10 DAYS OF RECEIPT via fax to number 1440 483 2950 or email to CTNM QARA philips com This Field Safety Notice and Addendum must be placed in your User Documentation until otherwise notified ACTIONS PLANNED BY PHILIPS Philips Healthcare is initiating this field correction consisting of The distribution of this Field Safety Notice FSN FSN88200490 and Addendum informing the operator of the issue and required actions and An immediate field correction of your system conducted by a Philips Healthcare Field Service Engineer FURTHER INFORMATION AND SUPPORT If you need any further information or support concerning this issue please contact your local Philips representative or local Philips Healthcare office For North America and Canada contact the Customer Care Solutions Center 1 800 722 9377 follow the prompts PHILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice pD H l LI DS Philips Healthcare Advanced Molecular Imaging 5 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector
5. Field Safety Notice pD E l LI DS Philips Healthcare Advanced Molecular Imaging 1 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction Dear Customer Recently a problem was reported from the field that the Flat Panel Detector FPD failed to remain securely locked in the deployed position If the issue were to re occur it could pose a risk for a person who is in the direct path of the FPD This Field Safety Notice FSN 88200490 and Addendum is intended to inform you about the following e what the problem is and under what circumstances it can occur e the actions that should be taken by the customer user in order to prevent risks for patients or users e the actions planned by Philips to correct the problem This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication It is important to understand the implications of this communication Please retain a copy with the equipment Instruction for Use If you need any further information or support concerning
6. Manual remain unaffected e These instructions may supersede portions of the current BrightView XCT User s Manual Selecting a protocol e To see the factory and custom Attenuation Correction and Localization protocols that are supplied with your system from the acquisition console click Tools Protocols or e Enter required patient data for a new study or select an existing patient study e Click Proceed The Patient Information tab now includes the Protocols tab and the Optional Visit Information tabs e Do one of the following e Click the protocol shortcut button of the desired protocol e Click the All Protocols button and select a protocol from the list Select a protocol without the LOC or AC designation e The selected protocol appears in the Patient Study panel e If an orange dot appears next to the protocol name appearing in the patient study panel this denotes an XCT component has been applied This may be altered from within the study by performing the following e Inthe SPECT acquisition page locate the drop down menu for XCT parameters located in the top right hand side of the page The drop down menu allows for the selection of e NONE e AC FAST e AC SLOW e LOCALIZATION FAST e LOCALIZATION SLOW KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited wit
7. art in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice pD H l LI DS Philips Healthcare Advanced Molecular Imaging 6 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction ADDENDUM INSTRUCTIONS TO CONTINUE LIMITED USE Study Type Action Required 180 amp 90 SPECT LOC e CEASE USE IMMEDIATELY until implementation of the appropriate field safety correction 180 amp 90 SPECT AC e CEASE USE IMMEDIATELY until implementation of the appropriate field safety correction 180 amp 90 SPECT NON AC NON LOC Unaffected Total Body Planar Unaffected Planar Static amp Dynamic Unaffected Cardiac 90 amp Relative 90 SPECT Unaffected IMPORTANT Continued use of the BrightView XCT and BrightView X Post Upgrade to XCT systems requires modification of acquisition protocols to remove XCT work steps e The following instructions will permit users to perform standard SPECT studies using the system in all head configurations associated with factory default protocols
8. eld Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction Cardiac 90 amp Relative 90 SPECT NON AC NON LOC UNAFFECTED Justification Cardiac 90 amp Relative 90 SPECT NON AC NON LOC procedures DO NOT require the deployment of the FPD Factory N A Protocols Studies NONE Affected Affected Instruction Continue normal use 180 SPECT NON AC NON LOC UNAFFECTED Justification 180 SPECT NON AC NON LOC procedures DO NOT require the deployment of the FPD Factory N A Protocols Studies NONE Affected Affected Instruction Continue normal use Justification Total Body Planar UNAFFECTED Total Body Planar procedures DO NOT require the deployment of the FPD Factory N A Protocols Studies None Affected Affected Instruction Continue normal use Planar Static amp Dynamic UNAFFECTED Justification Planar Static amp Dynamic procedures DO NOT require the deployment of the FPD Factory N A Protocols Studies NONE Affected Affected Instruction Continue normal use KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproductio
9. erwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice Philips Healthcare PHILIPS Advanced Molecular Imaging 4 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction ACTION TO BE TAKEN BY CUSTOMER USER 1 4 Immediately CEASE USE of the XCT Flat Panel Detector and stow the XCT FPD until the implementation of the appropriate field safety correction is completed by a Philips Healthcare Field Service Engineer FSE and the system is released for clinical use IMPORTANT Until your system has been released for clinical use The customer user is being advised to follow the INSTRUCTIONS TO CONTINUE LIMITED USE instructions described in the attached Addendum Read and understand this Field Safety Notice and Addendum The Addendum is intended to provide the information required for the continued use of your system prior to release by Philips FSE for Clinical use of the Flat Panel Detector Complete the Customer Response Form provided confirming that you have read and understand this Field Safety Notice and Addendum Return
10. hout the prior written consent of the copyright owner Revision 02 Status Approved KONINKLIJKE PHILIPS ELECTRONICS N V 2008 Field Safety Notice pD E l LI DS Philips Healthcare Advanced Molecular Imaging 8 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction e Select NONE and this will remove the XCT parameters associated with the present protocol in use On the Fly without amending the factory or custom protocols in the protocol list e The visual indicator Orange Dot next to the protocol name will be removed and the XCT acquisition parameters setup page will disappear e Proceed with the acquisition setup and patient study IMPORTANT When you change a parameter in an acquisition setup form you must click Update for the system to accept the new value WARNING Do not attempt to deploy or stow the FPD without first performing the Deploy Panel PPM or Stow Panel PPM Do not press the release button to deploy the Flat Panel X ray Detector in any position other than the Stow Panel PPM final position 90 degrees CNT 073105 03 Revision 02 Status Approved All rights are reserved Reproduction or transmission
11. in whole or in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner PHILIPS S Field Safety Notice pD H l LI DS Philips Healthcare Advanced Molecular Imaging 9 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction To stow the FPD 1 Touch the Stow Panel PPM on the touchscreen to move the system into the proper position 2 Pull the locking handle Figure1 out and push it away from you 180 degrees Figure 1 Deployed Flat Panel Detector FPD IMPORTANT Be careful not to rotate the FPD too far or it will collide with the gantry cover 3 Using the handle extend the FPD and the arm that supports it away from you to the right 90 degrees so that the entire assembly is parallel to the gantry 4 Extend the FPD towards you to the left 180 degrees and push it into the stowed position as shown in Figure 2 KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the
12. n or transmission in whole or in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner CNT 073105 03 Revision 02 Status Approved
13. nce when engaging the locking handle of the FPD in the deployed position With the locking handle in the locked position the FPD locking mechanism was not locked moved unexpectedly and contacted the imaging detector during system movement Philips investigation determined the internal linkage shaft broke preventing the FPD from being locked into its correct deployed position XCT Flat Panel Detector in the deployed position gt HAZARD INVOLVED If this problem were to re occur the FPD could swing inward unexpectedly during gantry motion and come in direct contact with the patient user or service personnel if they were in the path of the pivoting detector PHILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice Philips Healthcare PHILIPS Advanced Molecular Imaging 3 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the HOW TO IDENTIFY AFFECTED PRODUCTS appro
14. priate field safety correction BrightView XCT system Refer to the System Label affixed to the bottom right rear of the gantry cover The Description box identifies the affected system description BV XCT BrightView XCT System Label Example Philips Medical Systems Cleveland Inc 595 Miner Road Cleveland OH 44143 U S A Ta RPN tar SE ___ SYST BV XCT Tiit 3 8 MODERT NO REV SERIAL NO De ees 453560462131 BV 6000397 July 2013 mE vous ANPE PREG PHASE 400 480V 2BA oe 2 459800006201 REV A BrightView X system upgraded to a BrightView XCT system At the time of a BrightView X system upgrade to a BrightView XCT system an additional label is added to the bottom right rear of the gantry cover which considers the system has received the upgrade kit BrightView X to BrightView XCT Refer to the additional system label affixed at the time of the upgrade BrightView X system upgrade to a BrightView XCT System Label Example NOTE WHEN THE X RAY SUB ASSEMBLY IS PART OF THE BRIGHTVIEW UPGRADEABLE SYSTEM IT IS CONSIDERED AS A BRIGHTVIEW XCT SYSTEM AND WILL BE DESIGNATED AS FOLLOWS e 3 8 crystal Model Part No 453560462131 e 3 4 crystal Model Part No 453560749161 459800016271 REV A PHILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or oth
15. prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice pD E l LI DS Philips Healthcare Advanced Molecular Imaging 10 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropriate field safety correction Figure 2 Stowed Flat Panel detector FPD e When you push the FPD into the locked position you will hear a clicking sound and the FPD icon on the touchscreen displays the stowed position KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means CNT 073105 03 electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice PHILIPS Philips Healthcare Advanced Molecular Imaging 11 12 FSN88200490 17 June 2014 URGENT Field Safety Notice BrightView XCT and BrightView X upgraded with the XCT Flat Panel Detector Flat Panel Detector FPD may pivot inward unexpectedly as the gantry is rotated resulting in potential injury ACTION CEASE USE of XCT Flat Panel Detector until the implementation of the appropria
16. te field safety correction 180 amp 90 SPECT LOC CEASE USE IMMEDIATELY Justification Justification SPECT LOC procedures require the deployment of the FPD Factory Fast Body Localization Protocols Slow Localization Studies e Dual Isotope Tc Ga LOC Affected e Extremity Bone LOC e Indium SPECT LOC e Parathyroid SPECT LOC e TB SPECT LOC e Total Body Bone LOC Instruction Per this FSN SPECT LOC is to be ceased until implementation of Field Change Order FCO 88200490 180 amp 90 SPECT AC CEASE USE IMMEDIATELY Justification SPECT AC procedures require the deployment of the FPD Factory Cardiac Attenuation Correction Protocols Fast Body Attenuation Correction Studies e Brain SPECT AC Affected Cardiac One Day AC e Cardiac Two Day AC e Thallium SPECT AC e Gated SPECT AC e Cardiac Dual Isotope AC Instruction Per this FSN 88200490 SPECT LOC is to be ceased until implementation of Field Change Order FCO 88200490 ILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner CNT 073105 03 Revision 02 Status Approved Field Safety Notice PHILIPS Philips Healthcare Advanced Molecular Imaging 12 12 FSN88200490 17 June 2014 URGENT Fi
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