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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliSpace Portal DX/HX/EX, IntelliSpace Portal IX, and IntelliSpace Portal LX SPECT

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 Class 2 Recall
IntelliSpace Portal DX/HX/EX, IntelliSpace Portal IX, and IntelliSpace Portal LX SPECT
see related information
Date Posted August 14, 2014
Recall Status1 Open
Recall Number Z-2237-2014
Recall Event ID 68953
Premarket Notification
510(K) Numbers
K012009  K033326  K060937  K110151 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Code Information ISP DX/HX/EX; 881001 870081 85254 870044 870065 950104 85045 95027 82202 85319 87187 85170 85244 85218 95030 92003 85166 85172 87162 85330 85337 85164 95038 950129 870037 87193 82117 80905 85042 920005 80864 95057 950094 85104 85359 950084 85180 950071 850001 87201 87014 85588 85607 85623 85619 80974 85578 80752 85628 85627 85637 85601 80898 85599 85594 85629 85585 85636 85668 85584 85617 85581 81135 85645 85634 85625 85600 85640 85630 85639 85616 85642 85582 85673 85618 85670 85676 85598 85422 85577 85580 85631 85678 85589 85644 85648 85653 85621 85626 85638 85620 85596 85597 85614 85641 85615 85595 85675 85647 85649 85650 85651 85652 85654 85622 85587 85427 80973 85426 80939 85624 85635 82247 85583 85613 85590 95058 87204 870067 87030 87029 870031 870099 870085 82238 87151 95066 82146 85307 85327 870030 870086 87158 85308 85309 870078 85168 85069 82094 950149 82018 82008 87166 82109 85394 85249 35023 82240 85108 85317 36001 85311 870032 82141 82098 82237 81076 870052 81119 82118 79932 87017 87161 82099 85331 82145 81089 85025 85252 82093 87165 85165 81034 82035 85080 822020 87167 85031 35030 35009 80911 80965 870034 82086 82085 82082 81160 87170 87180 87003 95068 81063 82236 82006 360006 870053 81173 87182 87197 85026 870040 95071 82120 95029 82089 82124 87205 87192 95032 95005 87001 870082 950130 95037 87179 870050 870104 870106 870105 870043 360005 870076 82140 80991 85383 95010 81111 95021 85266 95036 82241 87194 870110 870012 870041 850015 87174 87191 87163 87150 870098 87189 87202 870109 87159 87200 870079 95075 870100 950153 95034 81171 870072 87178 81186 45007 95039 81188 950022 950116 85213 95007 87013 81117 95008 870049 950131 870092 950114 81008 870035 870026 87177 87172 87184 450009 950045 870074 950160 95069 870080 950096 87190 85314 85303 85256 85298 870038 870062 82148 95067 870108 310007 87198 95033 95065 870070 85235 870033 82135 142301 870028 82127 87171 870047 82201 87195 82134 82136 870102 870097 870042 950135 95025 85313 87185 310006 80071 87208 85239 95070 85312 35003 85258 82125 81190 85328 81065 85326 870075 85027 950138 822022 870029 87173 96000 920002 87011 35035 870083 85086 87018 82083 822009 87181 360008 870084 870064 870068 87186 870091 950033 950115 95059 87015 82133 82242 870027 870093 87016 950019 95074 950027 950029 950037 950075 950011 950144 950145 920008 950134 81192 450018 960001 870039 950025 950152 82107 950165 81172 950147 950072 950132 920001 822007 950092 81133 950169 85355 85145 870088 85082 85318 85103 85296 450003 950012 450004 950021 950102 950126 950140 950136 950086 450007 950004 950125 450015 950077 82036 950010 400014 822006 950053 82062 450017 950108 82064 950054 85396 450011 950058 950008 79940 870015 920004 85321 950127 950001 450001 950043 850018 950155 81130 450022 950087 85007 950168 95105 950073 85247 95107 950139 85246 950085 950146 950167 920007 950164 81035 950137 79936 95102 950112 85250 870071 950156 80979 85302 950097 79916 950166 950006 85357 85084 870077 81194 80914 85040 950141 35005 85353 85324 81179 95104 96021 950154 950055 950124 950052 81098 950123 950050 450012 950119 950122 950056 450013 950118 450014 950120 450020 950121 950051 950117 450010 950080 450008 950039 350015 850020 450005 950023 450002 950041 450006 950031 85033 450021 950143 96028 95009 96025 96027 96029 96030 96031 870094 85479 87164 95063 97056 950159 45008 96004 105015 36005 82022 870010 87183 85043 950161 87206 95080 85107 97060 85299 87203 400022 80418 55002 450025 105012 87199 870023 870025 950142 870011 950066 97054 85175 870103 87188 950002 960030 95061 450016 81191 95077 105002 85088 960002 105009 970001 82038 96003 950076 55001 31007 360007 87290 970002 81161 82100 95056 82069 870095 870056 950082 105005 870060 950057 85332 82147 105013 105014 970003 870107 950148 85081 105004 87210 870073 45006 95055 400023 81189 950016 97053 105011 31017 87160 96032 35010 85047 95079 97055 87196 87207 95100 45010 95076 97061 950100 450019 40014 96023 870013 85333 85261 360004 81178 36002 87169 35036 85371 950069 95073 950074 96022 96026 96108 950106 450023 960005 97062 105003 95085 105008 550001 95103 950095 95072 105010 870024 85643 ISP IX; 881030 16277 16279 40066 40006 40077 40233 400201 400235 40204 20001 20003 40264 40296 40294 40111 10492 15142 15929 40037 40031 40036 15764 16515 20009 15398 16371 40071 40024 600012 40110 600027 40092 40070 40168 40162 40244 40057 40136 40076 40101 400228 70032 70067 70044 70071 70022 70038 85421 70075 70081 70007 70053 70011 70019 70040 70018 70054 70015 70002 50015 70039 70009 50051 70066 50025 50054 70086 70035 50073 70047 70046 70031 70016 50067 70036 70069 50057 70079 70020 70013 50079 70037 70061 50052 70012 70059 70005 50022 70080 70064 70008 70024 70051 70006 70021 70045 50071 50074 70041 70033 70055 70050 70034 70014 50018 70010 50065 50085 50081 50060 70004 70056 70001 50076 70052 50053 70073 70025 70058 70049 85680 70017 70068 70003 50058 50062 50082 50086 50080 70048 70085 70043 50055 50056 70060 70057 70062 70042 70082 70070 70065 70063 70023 50059 50050 400225 40091 40103 40216 16367 40118 40119 40123 40124 40142 40156 400238 40041 40042 40102 40038 40022 40128 40280 40254 80863 400215 40112 40143 40054 400207 20006 40063 40256 20002 40237 40284 40215 40039 40287 40079 40222 40232 600005 600009 40121 40302 40018 40072 40161 40116 40034 40090 40278 40283 40285 40240 40338 40067 40045 40274 40253 40271 40339 40320 40282 40099 40126 600018 40288 40016 40028 40251 40052 40013 40263 40026 40292 40212 40260 40275 40206 40209 40213 40107 40159 40140 40307 40345 40132 16642 40114 40051 40050 16641 40089 40025 40060 400219 400217 400218 40035 400216 40023 400229 400214 40167 40069 40047 40075 40058 40094 40048 40257 40095 40082 40291 40297 600015 40218 40163 40100 40053 40226 40293 600002 40130 40221 40105 40106 600008 600025 600014 40062 40164 40085 40255 40211 40262 600007 40098 400208 400222 40008 40147 400200 400206 400202 600058 400204 600057 40265 40272 600011 20012 600001 600004 40073 400203 400205 400221 40154 400233 400234 40080 40065 400220 400224 400236 600059 40049 400232 40138 40135 600053 600055 40266 40104 40224 40225 40227 40236 40144 40207 40015 400213 600017 400210 40083 20008 40290 40059 40109 40117 40078 40252 40270 40081 68560 40115 40040 40153 40276 40217 40113 40120 40068 40097 40145 40146 40148 40150 40155 40158 600003 40043 600016 600054 600050 600051 40239 20013 40086 600023 40305 400237 600026 400230 600060 40258 600010 600022 600013 40046 40030 40056 40289 40129 40231 40268 40125 40166 40029 40210 20014 40220 40200 40202 40205 40208 40131 40295 40055 40230 40229 40139 40165 40228 40279 40281 40169 40020 40064 40017 400209 600021 40088 40096 40286 40214 68557 40027 600019 600020 40032 40269 400231 40009 40012 40108 40157 400223 40160 40011 40044 40061 40021 20007 20011 40007 400211 400212 40074 40019 20004 20005 40277 15634 40152 40273 20010 40149 15969 ISP LX SPECT; 881035 40084 40093 40087 40133 40141 40033 40134 400226 40003 400227 40001
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
978-659-7703
Manufacturer Reason
for Recall
The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare issued an Urgent Medical Device Correction letter dated July 28, 2014, via certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Philips Key Market representative would distribute the FSN internationally. Additionally, a Field Service Engineer would contact each site to schedule a time to install the software update. Customers with questions were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America and Canada customers were instructed to contact the Customer Care Solutions Center at 1-800-722-9377, option 1. For questions regarding this recall call 978-659-7703.
Quantity in Commerce 1099 Units
Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VT, WA, WI, WV, WY,Washington D.C. and Internationally to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Congo, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, and Yemen.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS HEALTHCARE
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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