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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 Device Recall IntelliSpace Portal DX/HX/EX, IntelliSpace Portal IX, and IntelliSpace Portal LX SPECT see related information
Date Initiated by Firm July 27, 2014
Date Posting Updated August 14, 2014
Recall Status1 Terminated 3 on February 02, 2016
Recall Number Z-2237-2014
Recall Event ID 68953
510(K)Number 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 169 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 OH 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
440-483-7600
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
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 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 = 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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