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U.S. Department of Health and Human Services

Class 2 Device Recall CIC Pro v4.1

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  Class 2 Device Recall CIC Pro v4.1 see related information
Date Initiated by Firm January 24, 2007
Date Posted February 01, 2008
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-0280-2008
Recall Event ID 45454
510(K)Number K032370  
Product Classification Central Station Monitoring System - Product Code DSI
Product GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware consists of a processing unit and a monitor)
Code Information All Serial numbers of Software Version 4.1: JA104050001GP, JA104050002GP, JA104050003GP, JA104050004GP, JA104050005GP, JA104050006GP, JA104050007GP, JA104050008GP, JA104050009GP, JA104050010GP, JA104050011GP, JA104050012GP, JA104050013GP, JA104050014GP, JA104050015GP, JA104050016GP, JA104050017GP, JA104050018GP, JA104050019GP, JA104050020GP, JA104050021GP, JA104050022GP, JA104050023GP, JA104050024GP, JA104050025GP, JA104270026GA, JA104270027GA, JA104270028GA, JA104270029GA, JA104270030GA, JA104270031GA, JA104270032GA, JA104270033GA, JA104290034GA, JA104290035GA, JA104290037GA, JA104290038GA, JA104290039GA, JA104290040GA, JA104290041GA, JA104290042GA, JA104290043GA, JA104290044GA, JA104290045GA, JA104290046GA, JA104290047GA, JA104290048GA, JA104290049GA, JA104290050GA, JA104290051GA, JA104290052GA, JA104290053GA, JA104290054GA, JA104290055GA, JA104290056GA, JA104290057GA, JA104290058GA, JA104290059GA, JA104290060GA, JA104290061GA, JA104290062GA, JA104360064GA, JA104360065GA, JA104360066GA, JA104360067GA, JA104360068GA, JA104360069GA, JA104360070GA, JA104360071GA, JA104360073GA, JA104360074GA, JA104360075GA, JA104360076GA, JA104360077GA, JA104360078GA, JA104360080GA, JA104360081GA, JA104360082GA, JA104360084GA, JA104360085GA, JA104360086GA, JA104360088GA, JA104360089GA, JA104360092GA, JA104360093GA, JA104360094GA, JA104360096GA, JA104360097GA, JA104360098GA, JA104360099GA, JA104360100GA, JA104360101GA, JA104360103GA, JA104360104GA, JA104360106GA, JA104360107GA, JA104360108GA, JA104360109GA, JA104360110GA, JA104360111GA, JA104360113GA, JA104370115GA, JA104370116GA, JA104370117GA, JA104370118GA, JA104370119GA, JA104370121GA, JA104370122GA, JA104370123GA, JA104370124GA, JA104370125GA, JA104370126GA, JA104370127GA, JA104370128GA, JA104370131GA, JA104370132GA, JA104370133GA, JA104370134GA, JA104370135GA, JA104370136GA, JA104370137GA, JA104370138GA, JA104370139GA, JA104370140GA, JA104370143GA, JA104370144GA, JA104370145GA, JA104370146GA, JA104370147GA, JA104370148GA, JA104370149GA, JA104370150GA, JA104370152GA, JA104370153GA, JA104370154GA, JA104370156GA, JA104370158GA, JA104370159GA, JA104370160GA, JA104370162GA, JA104370163GA, JA104370165GA, JA104370166GA, JA104370168GA, JA104370170GA, JA104370171GA, JA104370173GA, JA104370174GA, JA104370175GA, JA104370176GA, JA104370177GA, JA104380178GA, JA104380179GA, JA104380180GA, JA104380182GA, JA104380183GA, JA104380185GA, JA104380186GA, JA104380187GA, JA104380188GA, JA104380189GA, JA104380190GA, JA104380191GA, JA104380194GA, JA104380195GA, JA104380196GA, JA104380197GA, JA104380198GA, JA104380199GA, JA104380200GA, JA104380201GA, JA104380202GA, JA104380203GA, JA104380204GA, JA104380205GA, JA104380207GA, JA104380208GA, JA104380209GA, JA104380210GA, JA104380212GA, JA104380213GA, JA104380214GA, JA104380215GA, JA104380216GA, JA104380217GA, JA104380221GA, JA104380222GA, JA104380223GA, JA104380224GA, JA104380225GA, JA104380226GA, JA104380227GA, JA104380229GA, JA104380230GA, JA104380231GA, JA104380233GA, JA104380234GA, JA104380235GA, JA104380236GA, JA104380238GA, JA104380239GA, JA104380240GA, JA104380241GA, JA104380242GA, JA104380243GA, JA104380245GA, JA104380246GA, JA104380247GA, JA104380250GA, JA104380251GA, JA104380252GA, JA104380253GA, JA104380254GA, JA104380255GA, JA104380256GA, JA104380257GA, JA104380258GA, JA104380259GA, JA104380260GA, JA104380262GA, JA104380263GA, JA104380264GA, JA104380265GA, JA104380267GA, JA104380269GA, JA104380271GA, JA104380273GA, JA104380274GA, JA104380275GA, JA104380276GA, JA104380277GA, JA104380278GA, JA104380280GA, JA104380281GA, JA104380283GA, JA104380284GA, JA104380285GA, JA104380287GA, JA104380288GA, JA104380291GA, JA104380292GA, JA104380293GA, JA104390294GA, JA104390296GA, JA104390297GA, JA104390298GA, JA104390299GA, JA104390300GA, JA104390301GA, JA104390302GA, JA104390303GA, JA104390307GA, JA104390308GA, JA104390310GA, JA104390312GA, JA104390316GA, JA104390318GA, JA104390322GA, JA104390323GA, JA104390324GA, JA104390325GA, JA104420326GA, JA104420327GA, JA104420328GA, JA104420329GA, JA104420330GA, JA104420331GA, JA104420332GA, JA104420333GA, JA104420334GA, JA104420335GA, JA104420336GA, JA104420337GA, JA104420338GA, JA104420339GA, JA104420340GA, JA104420341GA, JA104420342GA, JA104420343GA, JA104420344GA, JA104420346GA, JA104420347GA, JA104420348GA, JA104420349GA, JA104420351GA, JA104420353GA, JA104420354GA, JA104420355GA, JA104420356GA, JA104420357GA, JA104420358GA, JA104420359GA, JA104420360GA, JA104420361GA, JA104420362GA, JA104420365GA, JA104420366GA, JA104420367GA, JA104420368GA, JA104420369GA, JA104420370GA, JA104420371GA, JA104420372GA, JA104420373GA, JA104420374GA, JA104420376GA, JA104420377GA, JA104420378GA, JA104420379GA, JA104420380GA, JA104420381GA, JA104420383GA, JA104420384GA, JA104420385GA, JA104430386GA, JA104430387GA, JA104430388GA, JA104430390GA, JA104430391GA, JA104430393GA, JA104430394GA, JA104430395GA, JA104430396GA, JA104430397GA, JA104430399GA, JA104430400GA, JA104430401GA, JA104430403GA, JA104430404GA, JA104430405GA, JA104430406GA, JA104430407GA, JA104430408GA, JA104430409GA, JA104430413GA, JA104430414GA, JA104430415GA, JA104430416GA, JA104430417GA, JA104430418GA, JA104430419GA, JA104430420GA, JA104430421GA, JA104430422GA, JA104430423GA, JA104430424GA, JA104430425GA, JA104430426GA, JA104430427GA, JA104430428GA, JA104430429GA, JA104430430GA, JA104430431GA, JA104430432GA, JA104430433GA, JA104430434GA, JA104430436GA, JA104430437GA, JA104430438GA, JA104430439GA, JA104430440GA, JA104430441GA, JA104430442GA, JA104430443GA, JA104440444GA, JA104440448GA, JA104440449GA, JA104440451GA, JA104440452GA, JA104440453GA, JA104440454GA, JA104440455GA, JA104440456GA, JA104440457GA, JA104440458GA, JA104440459GA, JA104440460GA, JA104440461GA, JA104440462GA, JA104440463GA, JA104440465GA, JA104440466GA, JA104440468GA, JA104440469GA, JA104440471GA, JA104440472GA, JA104440473GA, JA104440474GA, JA104440476GA, JA104440479GA, JA104440480GA, JA104440481GA, JA104440482GA, JA104440485GA, JA104440486GA, JA104440489GA, JA104440490GA, JA104440491GA, JA104460492GA, JA104460493GA, JA104460494GA, JA104460495GA, JA104460496GA, JA104460498GA, JA104460499GA, JA104460500GA, JA104460501GA, JA104460502GA, JA104460503GA, JA104460504GA, JA104460505GA, JA104460506GA, JA104460507GA, JA104460508GA, JA104460509GA, JA104460510GA, JA104460511GA, JA104460512GA, JA104460513GA, JA104460514GA, JA104460515GA, JA104460516GA, JA104460517GA, JA104460518GA, JA104460519GA, JA104460520GA, JA104460521GA, JA104460522GA, JA104460523GA, JA104460524GA, JA104460525GA, JA104460526GA, JA104460527GA, JA104460528GA, JA104460529GA, JA104460531GA, JA104460532GA, JA104460533GA, JA104460534GA, JA104460535GA, JA104460536GA, JA104460539GA, JA104460540GA, JA104460541GA, JA104460543GA, JA104460544GA, JA104460545GA, JA104460546GA, JA104460547GA, JA104460548GA, JA104460549GA, JA104460550GA, JA104460551GA, JA104460554GA, JA104460555GA, JA104460556GA, JA104460557GA, JA104460558GA, JA104460559GA, JA104460560GA, JA104460561GA, JA104460562GA, JA104460563GA, JA104460565GA, JA104460566GA, JA104460570GA, JA104460571GA, JA104460572GA, JA104460573GA, JA104460574GA, JA104460575GA, JA104460576GA, JA104460577GA, JA104460578GA, JA104460579GA, JA104470580GA, JA104470581GA, JA104470582GA, JA104470583GA, JA104470584GA, JA104470585GA, JA104470588GA, JA104470589GA, JA104470590GA, JA104470592GA, JA104470594GA, JA104470595GA, JA104470596GA, JA104470597GA, JA104470598GA, JA104470599GA, JA104470600GA, JA104470601GA, JA104470602GA, JA104470603GA, JA104470604GA, JA104470605GA, JA104470606GA, JA104470607GA, JA104470608GA, JA104470609GA, JA104470610GA, JA104470611GA, JA104470612GA, JA104470613GA, JA104470617GA, JA104470618GA, JA104470619GA, JA104470620GA, JA104470621GA, JA104470623GA, JA104470624GA, JA104470626GA, JA104470627GA, JA104470628GA, JA104470629GA, JA104470630GA, JA104470631GA, JA104470633GA, JA104470634GA, JA104470635GA, JA104470636GA, JA104470637GA, JA104470640GA, JA104470642GA, JA104470643GA, JA104470644GA, JA104470645GA, JA104470646GA, JA104470647GA, JA104470648GA, JA104470650GA, JA104470651GA, JA104480652GA, JA104480654GA, JA104480655GA, JA104480657GA, JA104480658GA, JA104480659GA, JA104480661GA, JA104480662GA, JA104480663GA, JA104480666GA, JA104480669GA, JA104480670GA, JA104480672GA, JA104480673GA, JA104480674GA, JA104480676GA, JA104480677GA, JA104480678GA, JA104480679GA, JA104480681GA, JA104480682GA, JA104480685GA, JA104480687GA, JA104480688GA, JA104480689GA, JA104480690GA, JA104480692GA, JA104480693GA, JA104480694GA, JA104480695GA, JA104480696GA, JA104480697GA, JA104480698GA, JA104480700GA, JA104480701GA, JA104480702GA, JA104480703GA, JA104480704GA, JA104480705GA, JA104480707GA, JA104480708GA, JA104480709GA, JA104480710GA, JA104480711GA, JA104480712GA, JA104480713GA, JA104480717GA, JA104480718GA, JA104490720GA, JA104490721GA, JA104490722GA, JA104490725GA, JA104490726GA, JA104490727GA, JA104490728GA, JA104490729GA, JA104490731GA, JA104490732GA, JA104490733GA, JA104490735GA, JA104490736GA, JA104490737GA, JA104490738GA, JA104490739GA, JA104490742GA, JA104490743GA, JA104490745GA, JA104490746GA, JA104490747GA, JA104490749GA, JA104490750GA, JA104490751GA, JA104490752GA, JA104490754GA, JA104490755GA, JA104490756GA, JA104490757GA, JA104490758GA, JA104490759GA, JA104490761GA, JA104490762GA, JA104490764GA, JA104490765GA, JA104490766GA, JA104490767GA, JA104490768GA, JA104490769GA, JA104490770GA, JA104500773GA, JA104500778GA, JA104500779GA, JA104500781GA, JA104500783GA, JA104500785GA, JA104500786GA, JA104500787GA, JA104500788GA, JA104500789GA, JA104500792GA, JA104500793GA, JA104500794GA, JA104500795GA, JA104500796GA, JA104500797GA, JA104500799GA, JA104500802GA, JA104500806GA, JA104500807GA, JA104500808GA, JA104500809GA, JA104500810GA, JA104500811GA, JA104500812GA, JA104500813GA, JA104500814GA, JA104500815GA, JA104500816GA, JA104500817GA, JA104500818GA, JA104500819GA, JA104500820GA, JA104500821GA, JA104500822GA, JA104500823GA, JA104500825GA, JA104500826GA, JA104500827GA, JA104500828GA, JA104500829GA, JA104500830GA, JA104500831GA, JA104500832GA, JA104500833GA, JA104500835GA, JA104500836GA, JA104500839GA, JA104500840GA, JA104500841GA, JA104500842GA, JA104500844GA, JA104500845GA, JA104500847GA, JA104500848GA, JA104500851GA, JA104500852GA, JA104500859GA, JA104500860GA, JA104500861GA, JA104500862GA, JA104500864GA, JA104500866GA, JA104500867GA, JA104500868GA, JA104510871GA, JA104510872GA, JA104510873GA, JA104510874GA, JA104510875GA, JA104510879GA, JA104510880GA, JA104510881GA, JA104510882GA, JA104510884GA, JA104510885GA, JA104510886GA, JA104510887GA, JA104510889GA, JA104510890GA, JA104510891GA, JA104510892GA, JA104510893GA, JA104510894GA, JA104510895GA, JA104510896GA, JA104510897GA, JA104510898GA, JA104510899GA, JA104510900GA, JA104510901GA, JA104510902GA, JA104510903GA, JA104510904GA, JA104510905GA, JA104510906GA, JA104510907GA, JA104510908GA, JA104510909GA, JA104510910GA, JA104510911GA, JA104510912GA, JA104510913GA, JA104510914GA, JA104510915GA, JA104510917GA, JA104510918GA, JA104510919GA, JA104510920GA, JA104510921GA, JA104510922GA, JA104510923GA, JA104510924GA, JA104510927GA, JA104510928GA, JA104510930GA, JA104510932GA, JA104510933GA, JA104510934GA, JA104510935GA, JA104510936GA, JA104510937GA, JA104510938GA, JA104510939GA, JA104510941GA, JA104510942GA, JA104510943GA, JA104510944GA, JA104510946GA, JA104510948GA, JA104510949GA, JA104510950GA, JA104510951GA, JA104510953GA, JA104510954GA, JA104510955GA, JA104510956GA, JA104510957GA, JA104510958GA, JA104510959GA, JA104510960GA, JA104510961GA, JA104510962GA, JA104510963GA, JA104510964GA, JA104510967GA, JA104510968GA, JA104510969GA, JA104510970GA, JA104510971GA, JA104510972GA, JA104510973GA, JA104510975GA, JA104510976GA, JA104510977GA, JA104510978GA, JA104520980GA, JA104520981GA, JA104520982GA, JA104520983GA, JA104520984GA, JA104520986GA, JA104520988GA, JA104520989GA, JA104520991GA, JA104520992GA, JA104520993GA, 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JA104531160GA, JA104531161GA, JA104531162GA, JA104531163GA, JA104531165GA, JA104531167GA, JA104531168GA, JA104531169GA, JA104531170GA, JA104531171GA, JA104531172GA, JA104531173GA, JA104531174GA, JA104531175GA, JA104531176GA, JA105021178GA, JA105021179GA, JA105021180GA, JA105021181GA, JA105021183GA, JA105021185GA, JA105021187GA, JA105021188GA, JA105021189GA, JA105021191GA, JA105021192GA, JA105021194GA, JA105021196GA, JA105021197GA, JA105021199GA, JA105021200GA, JA105021201GA, JA105021204GA, JA105021205GA, JA105021206GA, JA105021207GA, JA105021208GA, JA105021210GA, JA105021211GA, JA105021212GA, JA105021213GA, JA105021214GA, JA105021215GA, JA105021216GA, JA105021217GA, JA105021218GA, JA105021219GA, JA105021222GA, JA105021224GA, JA105021225GA, JA105021226GA, JA105021227GA, JA105021228GA, JA105021229GA, JA105021230GA, JA105021231GA, JA105021232GA, JA105021233GA, JA105021234GA, JA105021235GA, JA105021236GA, JA105021238GA, JA105021241GA, JA105021242GA, JA105021243GA, JA105021244GA, 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Recalling Firm/
Manufacturer		 General Electric Medical Systems Information Technology
8200 W Tower Ave
Milwaukee WI 53223-3219
For Additional Information Contact
414-362-2520
Manufacturer Reason
for Recall		 Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue.
FDA Determined
Cause 2		 Software design
Action GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07. As a Short Term Solution, GE recommends that user reboot of system according to instructions and precautions in Service Manual at least once every three months. Also, take the necessary precautions to ensure that system is shut down properly. This will decrease the likelihood of a continuous reboot. If system continues to reboot, GE suggest that user contact Technical Support at 1-800-588-7044 (Press Option 2) and ask for Technical Support. As for a Long Term Solution, GE will provide a software update that will rectify the issue as soon as an upgrade is available.
Quantity in Commerce 6,217 Units (1,549 OUS, 4,668 within US)
Distribution Worldwide Distribution - USA (excluding DE, HI, ID, MT, ND, SD, VT), Peurto Rico, Washington DC and including the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungaria, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherland, New Zealand, Norway, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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