PH I LI PS
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1. Field Safety Notice DH f Li PS Philips Healthcare Advanced Molecular Imaging 1 13 FSN 88200481 March 10 2074 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice Dear Customer Recently a problem was reported from the field of radius drive belt slippage in an ADAC Vertex System If the issue were to recur it could pose a risk of a potential serious injury or death for a patient if he or she is directly under the detector The affected systems are labeled ADAC Laboratories not Philips Healthcare This Field Safety Notice 88200481 is intended to inform you about 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 Healthcare 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 retain2. travel of the requested scan length KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights are reserved Reproducticn or transmission in whole or in part In any form or by any means CNT 073105 03 electronic mechanical of otherwise is prohibited without tha prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice PHILIPS Advanced Molecular Imaging 10 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death Philips Healthcare ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice Planar Static amp Dynamic Justification Planar Static amp Dynamic imaging may continue to be performed with modification of the scanning protocol and using the camera detectors in the 90 degree configuration GATED BLOOD POOL Factory Protocols e FIRST PASS RENAL FLOW PERF GFR SINGLE DETECTOR STATICS DUAL DET Including but not limited to the following exams using a factory default protocols listed above or user modified acquisition parameters e Renal Perfusion amp Flow Lung Perfusion amp Ventilation V Q MUGA Planar Gated Blood Pool
3. Body Contour option should be set to NOT INSTALLED 2 Using the Total Body Pre Programmed Motion PPM establish the orientation of the detectors in the 0 180 degree configuration prior to placing the patient on the table 3 Decrease the Anterior Superior detector height to its lowest possible position Keep the detector at this height for the duration of the scan Detector 1 Radius at 11 2cm as shown in the Picture 1 below 4 Lower the table as far as possible without encountering the gantry support rings or creating interference with the arm support board Approximate Table Height Z 32 0cm as shown in Picture s 1 2 and 3 Instruction Picture 1 Display Panel KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights are reserved Reproduction or wansmission in whols or in part In any form or by any means electronic mechanical or otherwise is prohibited without the prior writian consent of tha copyright owner Revision 02 Status Approved CNT 073105 03 Field Safety Notice DH l Li DS Philips Healthcare Advanced Molecular Imaging 8 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described tn Addendum NOTE The ADAC Cardio Sys
4. e First Pass e 3 Phase Bone Flow amp Statics 1 Studies Affected Planar Thyroid allowed with parallel hole collimator only All Planar Static amp Dynamic scans should use the detector head configuration of Relative 90 Cardiac 90 2 Utilize the Relative 90 or Cardiac 90 Pre Programmed Motion PPM prior to placing the patient on the imaging pallet 3 Depending on the required image output of Anterior Posterior Oblique Lateral etc the user may have to modify the number of detectors used on the acquisition setup page as shown in Pictures 4 5 and 6 4 Check the Detector field to make sure the proper detector is selected Examples of these steps are in the Acquiring Studies section of the Cardio Solus Vertex and Vertex PLUS User s Manual Verify the appropriate View ID is present prior to starting the study acquisition Instruction CAUTION Careful attention must be paid regarding the VIEW ID with the altered detector head configuration Modifications may be required to maintain accurate image labeling KONINKLIJKE PHILIPS HEALTHCARE 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 DH i Li DS Philips Healthcare Ad
5. Affected Gallium SPECT Indium SPECT MIBG SPECT l 131 SPECT 180 degree Single head acquisitions Brain SPECT 180 Circular SPECT 180 Non Circular SPECT Bone SPECT Per this FSN 88200481 Relative 180 SPECT is to be ceased until implementation of FCO KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 Al 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 DH l Li PS Philips Healthcare Advanced Molecular Imaging 7113 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice Total Body Planar l Justification Total Body Planar TB procedure may continue to be performed with modification of the scanning protocol and eliminating learn mode from the acquisition Protocols Studies Including but not limited to the following Affected TB Bone e TB Gallium e TB Indium e TB 131 VEF From the acquisition protocol set up page the
6. NINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or In pan in any form or by any means CNT 073 105 03 electronic mechanical or otherwise bs prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice PHILIPS Philips Healthcare Advanced Molecular Imaging 4 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice ACTIONS PLANNED BY Philips Healthcare is initiating this field correction consisting of PHILIPS HEALTHCARE e The distribution of o AField Safety Notice 88200481 informing the operator of the issue o An Addendum Instructions to Continue Limited Use to provide the information required for the continued use of your system and o A Customer Response Form requiring customer action e Philips Healthcare wili conduct the appropriate field correction through a Field Change Order The FCO will include the replacement of two 2 radius drive belts and the two 2 idler Pulleys FURTHER If you need any further information or support concerning th
7. a copy with the equipment Instruction for Use lf you need any further information or support concerning this issue please contact your local Philips Healthcare representative For North America and Canada contact the Customer Care Solutions Center 1 800 722 9377 Option 5 Enter site ID or follow the prompts This notice has been reported to the appropriate Regulatory Agencies Sincerely Director of Quality and Regulatory KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 CNT 073105 03 All rights are reserved Reproduction or tansmission in whole or in part In any form or by any means electronic mechanical or otherwise is prohibited without the pror writlen consent of the copyright canes Revision 02 Status Approved Field Safety Notice DH i LI PS Philips Healthcare Advanced Molecular Imaging 2 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice AFFECTED PRODUCTS e ADAC Vertex Classic e ADAC Vertex Plus e ADAC Vertex V60 ADAC Solus Please note that the ADAC Cardio is not affected by this Field Safety Notice The Cardio s
8. ation Factory e CIRCULAR G SPECT Protocols GATED NONCIRCULAR CARDIOLITE LOW DOSE TC VANTAGE TL VANTAGE TC REFERENCE TL REFERENCE GATED VANTAGE THALLIUM ECT GATED SPECT SINGLE NONE Affected Affected Instruction Continue normal use KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whale r 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 D H l Li DS Philips Healthcare Advanced Molecular Imaging 13 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice FIELD SAFETY NOTICE 88200481 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 have received read and understand the content within the Field Safety Notice FSN 88200481 and Addendum Instructions to Continue Use wi
9. iac 90 amp Relative 90 SPECT Unaffected IMPORTANT Continued use of the ADAC Vertex family of systems requires modification of detector head configurations and workflow not common to most Planar Static amp Dynamic and Total Body Planar protocols e The following instructions will permit users to perform standard static and dynamic planar studies using the system in a Relative 90 degree detector head configuration instead of the Relative 180 degree configuration most commonly associated with factory default protocols 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 Total impact to patient throughput and technologist workflow will vary per department Careful consideration must be taken in scheduling and desired outcomes must be understood regarding the limitations of detector configurations Quality Assurance QA studies as defined in the Cardio Solus Vertex and Vertex PLUS User s Manual remain unaffected Collimator exchange functions as defined in the Cardio Solus Vertex and Vertex PLUS User s Manual remain unaffected These instructions may supersede portions of the current Cardio Solus Vertex and Vertex PLUS User s Manual KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission In whole or in part In any form or b
10. is issue please INFORMATION AND contact your local Philips Healthcare representative or local Philips Healthcare SUPPORT office For North America and Canada contact the Customer Care Solutions Center 1 800 722 9377 option 5 Enter Site ID or follow the prompts KONINKLIJKE PHILIPS HEALTHCARE 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 DH i LI PS Philips Healthcare Advanced Molecular Imaging 5 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Coliimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice ADDENDUM INSTRUCTIONS TO CONTINUE LIMITED USE This document contains important information for the continued use of your equipment WARNING CEASE use of Relative 180 SPECT detector configuration CEASE use of the pinhole collimator CEASE USE IMMEDIATELY Planar Static amp Dynamic Continue use with detector configuration and workflow modifications noted below Card
11. ned triggering a permanent E Stop The permanent E stop cannot be cleared by an operator rendering the system inoperable without Field Service Engineer intervention Therefore should the Manual Override become inoperable the patient pallet cannot be lowered This situation has the potential to cause serious injury or death from the weight of the detector coming to rest on the patient HAZARD INVOLVED Note Normally the proper function of the Manual Override mode allows the operator to recover the basic system motions when a system is in a collision state KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights ere 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 writen consent of ihe copyright owner Revision 02 Status Approved Field Safety Notice PHILIPS Advanced Molecular Imaging 3 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death Philips Healthcare ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice HOW TO IDENTIFY e ADAC Vertex Classic AFFECTED PRODUCTS e ADAC Verte
12. tem is NOT affected by this Field Safety Notice Picture 2 Lateral view of the Superior Inferior Detector heads KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All ights are reserved Reproduction or transmission in whole er 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 E bed e Jj Field Safety Notice PHILIPS Advanced Molecular Imaging 9 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death Philips Healthcare ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice ee ea F i LETEL Picture 3 Patient pallet in the lowered position for Total Body Planar procedure 5 Position the patient on the patient pallet using aids and pillows as necessary Warning Maintain a minimum 5cm distance between the patient and the collimator face of the Anterior Superior detector 6 To ensure image quality maintain patient to detector proximity by using the hand controller to raise the patient pallet height and the Posterior Inferior detector head
13. th Limited Studies acknowledge Philips Healthcare s information and instructions in the Addendum Instructions to Continue Use with Limited Studies for the continued use of the system until a Philips Healthcare Representative conducts the appropriate field correction NAME PRINT TITLE PRINT SIGNATURE DATE IMPORTANT Please complete this Field Safety Notice 88200481 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 lete this form regardless of whether your system is still in use at your facility Comp KONINKLIJKE PHILIPS HEALTHCARE ELECTRONICS N V 2008 All rights ara reserved Reproduction or transmission In whole of in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written conseni of the copyright owner CNT 073 105 03 Revision 02 Status Approved
14. vanced Molecular Imaging 17 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice _ Picture 5 Detectors in 90 degree Configuration in Posterior Position KONINKLIJKE PHILIPS HEALTHCARE 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 n m r H F a Pri an i Field Safety Notice PH LI gt S Philips Healthcare FSN 88200481 Advanced Molecular Imaging 12 13 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice Cardiac amp Relative 90 SPECT NOT AFFECTED configur
15. x Plus e ADAC Vertex V60 e ADAC Solus Please note that the ADAC Cardio is not affected by this Field Safety Notice The system name can be identified by the system serial label which is located on the gantry by the input power ACTION TO BE TAKEN e CEASE use of Relative 180 degree SPECT procedures until BY CUSTOMER USER implementation of the Field Change Order FCO See Addendum for complete details e CEASE use of the pinhole collimator procedures until implementation of the FCO See Addendum for complete details e Continue use of Total Body Planar and Planar Static and Dynamic studies with workflow modifications and or detector modifications as described until implementation of the FCO See Addendum for complete details e 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 e A Customer Response Form has also been provided Please confirm by signing the attached form that you have read and understand this Field Safety Notice and Addendum 6 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 s For other countries please follow your local office contact information e This Field Safety Notice and Addendum must be placed in your User Documentation until otherwise notified KO
16. y any means CNT 073105 03 lecironic mechanical or othenvise Is prohibited without the prior written consent of the copyright owner Revision 02 Status Approved Field Safety Notice D Lf l i D S Philips Healthcare Advanced Molecular Imaging 6 13 FSN 88200481 March 10 2014 URGENT Field Safety Notice ADAC Vertex Classic Vertex Plus Solus and Vertex V60 Systems Detector head may drift resulting in potential patient injury or death ACTION CEASE USE of Relative 180 SPECT scans and procedures using the Pinhole Collimator LIMITED SYSTEM USE described in Addendum NOTE The ADAC Cardio System is NOT affected by this Field Safety Notice Pinhole Collimator CEASE USE IMMEDIATELY Justification Pinhole procedures require the detector heads to remain in the Relative 180 detector configuration Protocols Studies Including but not limited to the following Affected e Thyroid Per this FSN 88200481 Relative 180 SPECT is to be ceased until implementation of FCO p Relative 180 SPECT CEASE USE IMMEDIATELY Justification Relative 180 SPECT procedures require the detector heads to remain in the Relative 180 detector configuration Relative 90 detector configuration does not allow for a 360 degree orbit thus cannot be used as an alternative for Relative 180 SPECT acquisitions Factory CIRCULAR ECT Protocols NON CIRCULAR ECT SH SPECT COINCIDENCE MCD AC Studies Including but not limited to the following
17. ystem can be identified by e The word Cardio on the system s label e By the fixed 90 degree orientation of the detector heads and Vertex Cardio printed on the detector bonnet The affected systems are labeled ADAC Laboratories not Philips Healthcare Philips Healthcare received a report from the field about an ADAC Vertex Pius system During clinical use in the relative 180 degree configuration of the detector heads the radius drive belt in the superior positioned head slipped off the idler pulley allowing the detector head to drift down slowly approximately 1 cm per minute towards the patient This resulted in the operator having to perform an emergency removal of the patient from the system PROBLEM DESCRIPTION There have been no reports of serious injury or death as a result of this situation In the relative 180 degree configuration the superior positioned detector head radius drive belt slipped off the idler pulley allowing the detector head to drift down slowly approximately 1 cm per minute If this problem were to recur a drifting detector head could potentially come in direct contact with the patient Without immediate intervention a patient may become entrapped between the detector head and the patient pallet due to the operator s inability to engage the Manual Override mode This override mode becomes inoperable when the software detects unrequested motion as desig
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