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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Incisive CT

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  Class 2 Device Recall Philips Incisive CT see related information
Date Initiated by Firm December 24, 2020
Date Posted April 09, 2024
Recall Status1 Open3, Classified
Recall Number Z-1507-2024
Recall Event ID 94229
510(K)Number K180015  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product PHILIPS Incisive Computed tomography X-ray system
Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body

Model Number: 728143
Code Information UDI-DI: (01)00884838085015(21) Serial Numbers: 500092 500202 500264 500265 33002 500217 500046 33001 33003 500064 500102 500110 500111 500145 500168 500178 500211 500216 500222 500242 500252 500255 500282 500032 500073 500138 500034 500038 500069 500091 500135 500087 500041 500056 500089 500103 500105 500116 500123 500125 500136 500152 500200 500213 500219 500233 500256 500045 500024 500028 500122 500173 500283 500003 500020 500052 500075 500118 500134 500146 500149 500150 500218 500223 500232 500210 500225 500049 500067 500076 500081 500249 500129 500141 500142 500143 500144 500155 500156 500160 500161 500175 500181 500182 500185 500186 500187 500190 500191 500201 500204 500220 500221 500228 500235 500237 500250 500262 500266 500267 500268 500272 500275 500278 500284 500179 500195 500258 500031 500159 500074 500230 500240 500002 500035 500040 500158 500097 500043 500263 500205 500184 500274 500203 500128 500259 500080 500126 500206 500207 500171 500183 500188 500194 500059 500245 500248 500051 500189 500078 500153 500157 500229 500276 500199 500176 500177 500196 500047 500010 500036 500044 500079 500096 500106 500212 500226 500227 500241 500099 500060 500071 500082 500113 500120 500121 500124 500163 500215 500247 500251 500253 500254 500257 500269 500270 500271 500273 500279 500083 500132 500108 500164 500244 500001 500004 500011 500012 500013 500014 500017 500039 500054 500055 500058 500090 500127 500131 500197 500139 500154 500162 500231 500066 500048 500026 500062 500068 500100 500107 500109 500137 500174 500209 500214 500224 500234 500238 500239 500030 500133 500104 500018 500119 500061 500169 500029 500005 500019 500023 500180 500198 500208 500114 500130 500165 500166 500167 500042 500192 530147 530013 530052 530019 530035 530018 530146 530155 530148 530016 530012 530011 530014 530017 530039 530023 530132 530145 530040 530108 530036 530025 530095 530034 530031 530026 530083 530029 530154 530142 530015 530037 530033 530030 530149 530050 530021 530096 530143 530022 530081 530144 530002 530003 530004 530005 530006 530007 530008 530009 530010 530020 530024 530027 530028 530032 530038 530041 530042 530043 530044 530045 530046 530047 530048 530049 530051 530053 530054 530055 530056 530057 530058 530059 530060 530061 530062 530063 530064 530065 530066 530067 530068 530069 530070 530071 530072 530073 530074 530075 530076 530077 530078 530079 530080 530082 530084 530085 530086 530087 530088 530089 530090 530091 530092 530093 530094 530097 530098 530099 530100 530101 530102 530103 530104 530105 530106 530107 530109 530110 530111 530112 530113 530114 530115 530116 530117 530118 530119 530120 530121 530122 530123 530124 530125 530126 530127 530128 530129 530130 530131 530133 530134 530135 530136 530137 530138 530139 530140 530141 500098 500193 500093 540000 540001 540002 500065 500070 500261 500006 500112 500117 500050 500007 500022 500025 500027 500033 500037 500057 500063 500072 500094 500147 500148 500151 500236 500243 500246 500260 500277 500053 500021 500077 500095 500115 500170 500172
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact Philips Customer Care Solutions Center
978-482-2309
Manufacturer Reason
for Recall		 Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
FDA Determined
Cause 2		 Software design
Action Philips Healthcare issued Customer Information letter on 12/24/20 via USPS. Letter states reason for recall, health risk and action to take: You may continue to use your system(s) in accordance with the intended use. Refer to ADVICE ACTIONS BY CUSTOMER/USER of the customer letter for specific details regarding the issue descriptions and advice to customers. Should the customer feel uncertain regarding this action, please contact your local Philips representative. Field Change Orders (FCO72800727) involving software upgrade will be released to correct the issue at no charge to you. The planned release date is in Q1 2021. A Philips Field Service Engineer will contact you to schedule the upgrade at your site.
Quantity in Commerce 428 units
Distribution Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia Myanmar Nepal Netherlands Norway Pakistan Palestine, State of Peru Philippines Poland Puerto Rico Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Spain Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates United Kingdom Uzbekistan Viet Nam
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Philips Healthcare (Suzhou) Co., Ltd.
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