phıtıps

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
dilsat.oinar@ohilios.com +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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