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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Solar 8000M System

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  Class 2 Device Recall GE Healthcare Solar 8000M System see related information
Date Initiated by Firm April 02, 2008
Date Posted January 05, 2009
Recall Status1 Terminated 3 on May 17, 2012
Recall Number Z-0285-2009
Recall Event ID 49135
510(K)Number K012467  
Product Classification detector and alarm, arrhythmia - Product Code DSI
Product GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment
Code Information Serial numbers: PA1257732, PA1257733, PA1257734, SCZ07200027GA, SCZ07200028GA, SCZ07200029GA, SCZ07200030GA, SCZ07200031GA, SCZ07200032GA, SCZ07200033GA, SCZ07200034GA, SCZ07200035GA, SCZ07220036GA, SCZ07220037GA, SCZ07220038GA, SCZ07220039GA, SCZ07220040GA, SCZ07220041GA, SCZ07220042GA, SCZ07220043GA, SCZ07220044GA, SCZ07220045GA, SCZ07220046GA, SCZ07220047GA, SCZ07220048GA, SCZ07220049GA, SCZ07220050GA, SCZ07220051GA, SCZ07220052GA, SCZ07220053GA, SCZ07220054GA, SCZ07220055GA, SCZ07220056GA, SCZ07220058GA, SCZ07220059GA, SCZ07220060GA, SCZ07220061GA, SCZ07220067GA, SCZ07220068GA, SCZ07220069GA, SCZ07220070GA, SCZ07220072GA, SCZ07220073GA, SCZ07220076GA, SCZ07220077GA, SCZ07220078GA, SCZ07220079GA, SCZ07220080GA, SCZ07220081GA, SCZ07220082GA, SCZ07220084GA, SCZ07220085GA, SCZ07220086GA, SCZ07220087GA, SCZ07220088GA, SCZ07220089GA, SCZ07220090GA, SCZ07220091GA, SCZ07220092GA, SCZ07220093GA, SCZ07220094GA, SCZ07220095GA, SCZ07220096GA, SCZ07220097GA, SCZ07220098GA, SCZ07220099GA, SCZ07220100GA, SCZ07220101GA, SCZ07220102GA, SCZ07220103GA, SCZ07220104GA, SCZ07220105GA, SCZ07220106GA, SCZ07220107GA, SCZ07220108GA, SCZ07220109GA, SCZ07220110GA, SCZ07220111GA, SCZ07220112GA, SCZ07220113GA, SCZ07220114GA, SCZ07220115GA, SCZ07230116GA, SCZ07230158GA, SCZ07230162GA, SCZ07230163GA, SCZ07230164GA, SCZ07230165GA, SCZ07230166GA, SCZ07230167GA, SCZ07230168GA, SCZ07230169GA, SCZ07230170GA, SCZ07230171GA, SCZ07230172GA, SCZ07230173GA, SCZ07230174GA, SCZ07230175GA, SCZ07230176GA, SCZ07230177GA, SCZ07230178GA, SCZ07230179GA, SCZ07230180GA, SCZ07230181GA, SCZ07230182GA, SCZ07230183GA, SCZ07230184GA, SCZ07230185GA, SCZ07230191GA, SCZ07230209GA, SCZ07230210GA, SCZ07230211GA, SCZ07230212GA, SCZ07230213GA, SCZ07230214GA, SCZ07230215GA, SCZ07230216GA, SCZ07230217GA, SCZ07230218GA, SCZ07230219GA, SCZ07230220GA, SCZ07230221GA, SCZ07230222GA, SCZ07230223GA, SCZ07230224GA, SCZ07230225GA, SCZ07230226GA, SCZ07230227GA, SCZ07230228GA, SCZ07230229GA, SCZ07230232GA, SCZ07240255GA, SCZ07240256GA, SCZ07240257GA, SCZ07240258GA, SCZ07240259GA, SCZ07240260GA, SCZ07240261GA, SCZ07240262GA, SCZ07240263GA, SCZ07240264GA, SCZ07240265GA, SCZ07240266GA, SCZ07240267GA, SCZ07240268GA, SCZ07240269GA, SCZ07240270GA, SCZ07240271GA, SCZ07240272GA, SCZ07240273GA, SCZ07240274GA, SCZ07240275GA, SCZ07240276GA, SCZ07240277GA, SCZ07240278GA, SCZ07240279GA, SCZ07240280GA, SCZ07240281GA, SCZ07240282GA, SCZ07240283GA, SCZ07240284GA, SCZ07240285GA, SCZ07240286GA, SCZ07240287GA, SCZ07240288GA, SCZ07240289GA, SCZ07240290GA, SCZ07240291GA, SCZ07240292GA, SCZ07240293GA, SCZ07240294GA, SCZ07240295GA, SCZ07240296GA, SCZ07240297GA, SCZ07240298GA, SCZ07240299GA, SCZ07240300GA, SCZ07240301GA, SCZ07240302GA, SCZ07240303GA, SCZ07240304GA, SCZ07240306GA, SCZ07240307GA, SCZ07240308GA, SCZ07240310GA, SCZ07240321GA, SCZ07240323GA, SCZ07240324GA, SCZ07240329GA, SCZ07240346GA, SCZ07240347GA, SCZ07240348GA, SCZ07240349GA, SCZ07240350GA, SCZ07240351GA, SCZ07240352GA, SCZ07240353GA, 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SCZ07280749GA, SCZ07280753GA, SCZ07280754GA, SCZ07280755GA, SCZ07280756GA, SCZ07280757GA, SCZ07280758GA, SCZ07280759GA, SCZ07280760GA, SCZ07280761GA, SCZ07280762GA, SCZ07280763GA, SCZ07280764GA, SCZ07280765GA, SCZ07280766GA, SCZ07280767GA, SCZ07280768GA, SCZ07280769GA, SCZ07280770GA, SCZ07280771GA, SCZ07280772GA, SCZ07280773GA, SCZ07280774GA, SCZ07280775GA, SCZ07280776GA, SCZ07280777GA, SCZ07280778GA, SCZ07280779GA, SCZ07280780GA, SCZ07280781GA, SCZ07280782GA, SCZ07280783GA, SCZ07280784GA, SCZ07280785GA, SCZ07280786GA, SCZ07280787GA, SCZ07280788GA, SCZ07280789GA, SCZ07280790GA, SCZ07280791GA, SCZ07280792GA, SCZ07280793GA, SCZ07280794GA, SCZ07280795GA, SCZ07280796GA, SCZ07280797GA, SCZ07280798GA, SCZ07280802GA, SCZ07280803GA, SCZ07280809GA, SCZ07280810GA, SCZ07280811GA, SCZ07280812GA, SCZ07280813GA, SCZ07280814GA, SCZ07280815GA, SCZ07280816GA, SCZ07280817GA, SCZ07280818GA, SCZ07280819GA, SCZ07280820GA, SCZ07280821GA, SCZ07280822GA, SCZ07280823GA, SCZ07280824GA, SCZ07280825GA, SCZ07280826GA, SCZ07280827GA, SCZ07280828GA, SCZ07280829GA, SCZ07280830GA, SCZ07290860GR, SCZ07290861GA, SCZ07290862GA, SCZ07290863GA, SCZ07290864GA, SCZ07290865GA, SCZ07290866GA, SCZ07290867GA, SCZ07290868GA, SCZ07290869GA, SCZ07290870GA, SCZ07290871GA, SCZ07290872GA, SCZ07290873GA, SCZ07290874GA, SCZ07290875GA, SCZ07290876GA, SCZ07290877GA, SCZ07290878GA, SCZ07290879GA, SCZ07290880GA, SCZ07290881GA, SCZ07290882GA, SCZ07290883GA, SCZ07290884GA, SCZ07290885GA, SCZ07290886GA, SCZ07290887GA, SCZ07290888GA, SCZ07290889GA, SCZ07290890GA, SCZ07290891GA, SCZ07290892GA, SCZ07290893GA, SCZ07290894GA, SCZ07290895GA, SCZ07290896GA, SCZ07290897GA, SCZ07290898GA, SCZ07290899GA, SCZ07290900GA, SCZ07290901GA, SCZ07290902GA, SCZ07290903GA, SCZ07290904GA, SCZ07290905GA, SCZ07290906GA, SCZ07290907GA, SCZ07290908GA, SCZ07290909GA, SCZ07290910GA, SCZ07290911GA, SCZ07290912GA, SCZ07290913GA, SCZ07290914GA, SCZ07290915GA, SCZ07290917GA, SCZ07290919GA, SCZ07290920GA, SCZ07290921GA, SCZ07290922GA, SCZ07290923GA, SCZ07290924GA, SCZ07290926GA, SCZ07290927GA, SCZ07290930GA, SCZ07290931GA, SCZ07290932GA, SCZ07290933GA, SCZ07290934GA, SCZ07290935GA, SCZ07290936GA, SCZ07300937GA, SCZ07300938GA, SCZ07300939GA, SCZ07300940GA, SCZ07300941GA, SCZ07300942GA, SCZ07300943GA, SCZ07300944GA, SCZ07300945GA, SCZ07300946GA, SCZ07300947GA, SCZ07300948GA, SCZ07300949GA, SCZ07300950GA, SCZ07300951GA, SCZ07300952GA, SCZ07300953GA, SCZ07300954GA, SCZ07300955GA, SCZ07300956GA, SCZ07300957GA, SCZ07300958GA, SCZ07300959GA, SCZ07300960GA, SCZ07300961GA, SCZ07300962GA, SCZ07300963GA, SCZ07300964GA, SCZ07300965GA, SCZ07300966GA, SCZ07300967GA, SCZ07300968GA, SCZ07300969GA, SCZ07300970GA, SCZ07300971GA, SCZ07300972GA, SCZ07300973GA, SCZ07300974GA, SCZ07300975GA, SCZ07300976GA, SCZ07300977GA, SCZ07300978GA, SCZ07300979GA, SCZ07300980GA, SCZ07300981GA, SCZ07300982GA, SCZ07300983GA, SCZ07300984GA, SCZ07300985GA, SCZ07300986GA, SCZ07300987GA, SCZ07300991GA, SCZ07300992GA, SCZ07300993GA, SCZ07300994GA, 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SCZ07311198GA, SCZ07311199GA, SCZ07311200GA, SCZ07311201GA, SCZ07311202GA, SCZ07311203GA.SCZ07311204GA, SCZ07311205GA, SCZ07311206GA, SCZ07311207GA, SCZ07311208GA, SCZ07311209GA, SCZ07311210GA, SCZ07311211GA, SCZ07311212GA, SCZ07311213GA, SCZ07311214GA, SCZ07311215GA, SCZ07311216GA, SCZ07311217GA, SCZ07311218GA, SCZ07311219GA, SCZ07311220GA, SCZ07311221GA, SCZ07311222GA, SCZ07311223GA, SCZ07311224GA, SCZ07311225GA, SCZ07311226GA, SCZ07311227GA, SCZ07311228GA, SCZ07311229GA, SCZ07311230GA, SCZ07311231GA, SCZ07311232GA, SCZ07311233GA, SCZ07311234GA, SCZ07311235GA, SCZ07311236GA, SCZ07311237GA, SCZ07311238GA, SCZ07311239GA, SCZ07311240GA, SCZ07311241GA, SCZ07311242GA, SCZ07311243GA, SCZ07311244GA, SCZ07311245GA, SCZ07311246GA, SCZ07311247GA, SCZ07311248GA, SCZ07311249GA, SCZ07311250GA, SCZ07311251GA, SCZ07311252GA, SCZ07311253GA, SCZ07311254GA, SCZ07311255GA, SCZ07311256GA, SCZ07311257GA, SCZ07311258GA, SCZ07321282GA, SCZ07321283GA, SCZ07321284GA, SCZ07321285GA, SCZ07321286GA, 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Recalling Firm/
Manufacturer		 GE Healthcare
9900 Innovation Drive
Wauwatose WI 53226
For Additional Information Contact
608-221-1551
Manufacturer Reason
for Recall		 A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed in other monitoring applications. The software error will result in a reset of the Solar 8000M/i, causing a loss of monitoring for approximately 1-2 minutes a
FDA Determined
Cause 2		 Software design
Action A GE Healthcare consignee letter was sent out 9/9/08. The letter dated August 26, 2008 was addressed to Healthcare Administrator/Risk Manger. The letter described the problem, product and provided recommendation.
Quantity in Commerce 2782
Distribution Nationwide to: AL, AR, AZ, CA, FL, GA, IA, ID, IL, IN, MA, MI, MN, MO, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, and WI. OUS to include: Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, France, Germany, Indonesia, Ireland, Italy, Jordan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Pakistan, Saudi Arabia, Spain, Sweden, United Kingdom, and Venezuela.
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 = GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
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