Saha Giivenli$i Uyarrsr PHITIPS Philips Healthcare -112- BIU MR FSN781 00432 Hazitan 2014 ACIL - Saha Gi.ivenli$i Uyansr lngenia MR sistemleri Yanftghkla manyetik M10 somunlarryla monte edilen lngenia arka kapak seti Sayrn M0Sterimiz, lngenia MR Sistemleri'nde, arka kapaklar grkarrldrgrnda servis muhendisleri ve cihazrn yakrnrndaki kigiler i9in risk oluSturabilecek bir sorun tespit edilmigtir. Hasta igin herhangi bir risk yoktur. Bu FSN781 00432, sizi aiagrdaki konularda bilgilendirmek igin hazrrlanmrgtrr: o . . Sorunun ne oldugu ve hangi kogullarda meydana geldi$i Riski ortiadan kaldrrmak igin kullanrcr tarafrndan yaprlmasr gerekenler Sorunu 9ozmek igin Philips tarafrndan yaprlmasr planlanan eylemler. Bu belge ekipmanrnlzrn her zaman gUvenli ve do0ru gekilde kullanrlmasr igin iinemli bilgiler igeril Lutfen bu belgede anlatrlan bilgilerden haberdar olmasr gereken tum gahganlannrzla birlikte a$agrdaki bilgileri gdzden gegirin. Bu belgede belirtilenlerin ne gekilde uygulamaya gegirileceginin anla$rlmasr bUyilk 6nem ta$rr. Liitfen ekipman ile birlikte Kullanrm Talimatlan'nrn bir kopyasrnt bulundurun. Bu konuyla ilgili daha fazla bilgi veya destege gereksinim duyarsanlz lutfen yerel Philips temsilcinizle g0r0gun: <Philips temsilcisinin iletigim bilgileri KM/ulke tarafrndan doldurulacaktrr> Bu uyarr, gegerli duzenlemelere gore ilgili Duzenleyici Kuruma bildirilecektir Philips bu sorun nedeniyle olugan her turl0 aksakhktan dolayt 6zur diler. Saygrlanmla, <lmza, BS/BU/BL veya GS&S/KM Yonetimi tarafrndan imzalanacak> <lsim> <Girrevi> BIU MR Best - Hollanda oEP114579 Saha GUvenli!i Uyarrsr PHITIPS Philips Healthcare -212- BIU MR FSN781 00432 Hazian 2014 ACiL - Saha Gi.ivenli$i Uyansr lngenia MR sistemleri Yanftghkla manyetik M10 somunlarryla monte edilen lngenia arka kapak seti etxilereH URUNLER Aralrk 2013 ve Mart 2014 tarihleri arastnda gonderilen lngenia 1.5T ve 3.07 Uriinleri. SORUNUN TANIMI Kurulumu yapan kigiye lngenia arka kapak setiyle birlikte A4 paslanmaz Eelik somun yerine yanlrghkla manyetik M10 somunu (dort adeo g0nderilmigtir. olasr reHlixeteR Sistem servisi srrasrnda manyetik alan nedeniyle yuksek htza gtkan manyetik M10 somununun mekanik etkisi tehlike olugturur Sistem servis muhendisleri ilgili somunlarrn manyetik olmasrnr beklemez. Manyetik M10 somunu milhendislerin ellerinden veya ceplerinden frrlayrp sistem t neline garparak tekrar geri ddnebilir. Uqan nesne sistem tunelinin yaktntnda veya iginde bulunan kigilere ya da dioer personele garpabilir. Arka kapak seti servis strastnda gtkartldtgt igin sistemin klinik kullanrmr srrasrnda tehlike olugmast beklenmez. ETK|LENEN URUNLER NASIL BELiRLENiR 96 adede kadar lngenia sisteminin kurulumunda manyetik somun kullanllmlg olabilir ancak sistemi drgafldan inceleyerek manyetik somun kullantllp kullantlmadt0tnr belirlemek m0mkun degildir. MUgTERilKULLANICI Sistem Philips tarafrndan incelenmeden ve/veya duzeltilmeden hastane teknik ekibinin veya Philips servis mtlhendisleri drgrnda herhangi birinin arka kapaklarl TARAFINOAN YAPILMASI GEREKENLER sdkmesine izin vermeyin. PHILIPS TARAFINDAN Tum Philips kurulum ve servis muhendisleri bu tehlike konusunda uyarllmlgtlr. YAPILMASI PLANLANAN EYLEMLER Philips alan servis miihendislerini lngenia arka kapak seti somunlartnl incelemeye ve gerekirse manyetik olmayan paslanmaz gelik somunlarla degigtirmeye yiinlendirmek igin FCO781 00432 referans numarah Saha Deoisiklik Emri yayrmlanmaktadrr. Bu programla ilgili olarak Philips ile iletigime gegmeniz gerekirse lutfen FCO781 00432 referansrnr verin. iLAvE BiLGi vE DESTEK BIU MR Best - Hollanda Bu konuyla ilgili daha fazla bilgi veya destege gereksinim duyarsanlz lutfen yerel Philips temsilcinizle g0ru9un. Medikal Ruhsatlandrrma Uzmant - Dilgat Ptnar [email protected] +90-530-7039853 ve +90+21 6{36-1 721 DEP'114579 PHITIPS Field Safety Notice Philips Healthcare -1t2- BIU MR FSN781 00432 June 20'14 URGENT - Field Safety Notice lngenia MR systems lngenaa rear cover set erroneously mounted with magnetic Ml0 nuts Dear Cuslomer, A problem has been detected in the lngenia MR Systems that, if the rear covers are to be removed, could pose a risk for the service engineers and possible bystanders. There is no patient risk involved. This FSN781 00432 is intended to inform you about: . . . what the problem is and under what circumstances it can occur the actions that should be taken by the user in order to prevent risks the actions planned by Philips to correcl 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. lt is important to understand the implications of this communication. Please retain a copy with the equipment lnstruction for Use. lf )/ou need any further information or support concerning this issue, please contact your local Philips representative: <Philips representative contact details to be completed by the KM / country> This notice will be reported to the appropriate Regulatory Agency pursuant to applicable regulations Philips apologizes for any inconveniences caused by this problem. Sincerely, <Signature, to be signed by Senior Management of the BS/BU/BL or GS&S/KM> <Name> <Function> BIU MR Best - the Nethe,lands DEPtt4579 PHITIPS Field Safety Notice Philips Healthcare -2t2- BIU MR FSN781 00432 June 2014 URGENT - Field Safety Notice lngenia MR systems lngenia rear cover set erroneously mounted with magnetic M10 nuts AFFECTED PRODUCTS lngenia 1.5T and 3.0T shipped between December 2013 and March 2014. ROBLEM DESCRIPTION ln the lngenia rear cover set magnetic M10 nuts (four) were erroneously supplied to the installer instead of A4 stainless steel nuts. HAZARD INVOLVED The hazard is a mechanical impact of a magnetic M10 nut accelerated to high speed by the magnetic field during service of the system. Service engineers of the system do nol expect these nuts to be magnetic. The magnetic M10 nut can fly from their hands or pockets and fly through the bore of the system and possibly back to them. The flying object may strike the individual or other personnel close to or in the bore of the system. Because the removal of the rear cover set is performed during service, the hazard is not expected to occur during clinical use of the system. HOW TO IDENTIFY AFECTEO PRODUCTS Up to 96 lngenia systems may have been installed with the magnetic nuls, but it is not possible to determine by external examination of the system whether magnetic nuts were used. ACTION TO BE TAKEN BY CUSTOMER / USER Do not let hospital technical slaff or any person other than Philips service engineers dismount the rear covers before the system is inspected and/or corrected by Philips. ACTIONS PLANNED BY All Philips installation and service engineers have been alerted to this hazard. PHILIPS A Field Change Order with reference FCO781 00432 is being released directing Philips {ield service engineers to inspect the lngenia rear cover set nuts and replace them if needed with non-magnetic stainless steel nuts. Should you need to communicate with Philips with regard to this program, please reference FCO781 00432. FURTHER INFORMATION AND SUPPORT BIU MR Best - lhe Netherlands lf you need any further information or support concerning this issue, please contact your local Philips representative. DEP114579
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