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1. Field Safety Notice pD pet i LI DS Philips Medical Systems GXR 1 2 FSN MA FCO 71200027 2007 Nov 23 URGENT Field Safety Notice Digital Diagnost family Special attention with use of Autostitching functionality Applicable to 712 050 052 055 060 062 Dear Customer a problem has been detected in the use of the Auto stitching functionality with Philips products listed above that if it were to re occur could pose a risk for patients This Field Safety Notice 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 to educate clinical user 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 1 PROBLEM DESCRIPTION The auto stitching functionality implemented in above Philips products is a computerized mechanism which joins individual images to a combined stitched overview This computerized mechanism can not fully replace the experienced decision from a radiologist It is advised by Philips and described within the existing product manual t2. hat stitched images and their manual manipulations need to be verified by the operator and radiologist before used for diagnosis and surgery 2 ACTIONS TO BE TAKEN BY THE CUSTOMER USER The system can be used as usual Operators and radiologist might need to be re trained on auto stitching At least before surgery a radiologist need to be consulted before surgery 3 ACTIONS PLANNED BY PHILIPS Philips will update user manual for coming installations and train their own application force For customers with the need of re training special on site trainings sessions will be offered PHILIPS KONINKLIJKE PHILIPS ELECTRONICS N V 2007 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 Form UXW 060003a2 2007 09 20 Philips Medical Systems 2 2 FSN MA FCO 71200027 2007 Nov 23 4 FURTHER INFORMATION AND SUPPORT If you need any further information or support concerning this issue please contact your local Philips representative Switzerland German 0800 80 3000 Switzerland French 0800 80 3001 This notice has been reported to the appropriate Regulatory Agency Philips apologizes for any inconveniences caused by this problem Sincerely R Schultz Safety Manager for Medical Devices Philips Medical Systems DMC GmbH
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