Date Initiated by Firm | October 06, 2017 |
Create Date | February 04, 2018 |
Recall Status1 |
Terminated 3 on July 02, 2019 |
Recall Number | Z-0520-2018 |
Recall Event ID |
78863 |
510(K)Number | K160743 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Philips Ingenuity Core 128 computed tomography x-ray system |
Code Information |
Ingenuity Core 128 - 728323 SN# - 320002 320001 320006 320003 320005 320010 320008 320030 320037 320019 320033 320018 320024 320029 320026 320031 320059 320054 320058 320074 320081 336207 320079 320078 320069 320080 320073 320115 320092 320090 320083 320084 320082 320096 320133 320103 320100 320101 336015 320138 32021 320107 320111 320132 320126 320114 336016 320248 320123 336011 320099 320122 336018 320134 320215 320146 320119 336013 320125 320131 32058 32013 320129 32085 320147 336012 320128 336017 336025 32042 336023 32012 320206 336034 320144 32018 336029 32016 336028 320227 32026 32032 32099 320214 32015 32054 336046 336070 32024 336027 32010 336103 32059 336069 32055 336040 32033 320204 32037 32043 32047 32034 32036 32049 32041 336072 336075 336044 32044 32070 32069 32050 32091 32089 32092 32072 32048 336067 32052 32102 32062 32046 32074 32056 32073 336091 336071 336059 320233 336064 336068 32057 336102 32053 32060 32071 336083 32064 32081 32106 32079 32068 32132 336051 32063 336060 32100 32075 336076 32051 32101 336144 336148 336085 336066 320230 32082 336077 32077 32090 336118 336086 32094 336080 336078 32078 32087 320217 32080 32001 32065 32088 320232 320213 336090 32067 336082 32160 32122 32130 336088 32098 32108 32093 320250 336092 336093 336073 32084 320220 32111 336087 32109 32105 336097 336098 32104 32103 32096 32121 336094 336079 32086 336106 336099 336089 32095 336096 32113 32112 32110 320210 336105 336081 32120 336130 32114 32119 32159 32118 32156 336095 320241 336104 336108 32143 336115 336129 32116 336140 336122 336111 336127 32135 336107 32168 320236 336100 320222 320221 32126 32129 32097 320216 320231 320201 320200 320207 336109 336141 320202 320229 32115 336110 32117 320203 336123 336116 336132 320283 336119 336151 32124 336131 336138 320209 32123 336139 336112 336124 320212 320208 320218 336128 336101 32140 320243 32133 32141 320271 336214 336133 32151 32146 336137 320239 320219 320237 320267 32125 336120 336126 320235 32131 32134 32152 320225 320224 336113 336142 336157 320223 336135 336125 30023 32142 320226 52049 320211 32128 320234 320247 320228 336147 32139 336150 336166 320238 336170 32136 32137 32145 32127 32138 32161 336201 320251 320263 32157 336188 336152 336154 336160 320245 336117 320242 336156 336143 336194 32144 32148 32028 32150 336153 32147 320253 336134 336195 336136 336232 336114 336146 320252 336158 320262 320254 320258 336167 32154 336145 32165 32163 336190 336161 336149 336182 320246 336169 32153 336175 336164 32149 320282 320255 320257 336181 320240 32155 336213 32158 336196 52023 336183 336184 336185 320261 32164 52028 336186 336174 320284 32162 336228 336191 320268 336248 320270 336155 32167 336163 336159 336193 336172 336162 336173 336176 336165 336204 336200 336180 320256 32166 320272 320273 336192 320265 336199 336177 336168 336178 336197 336171 320266 336216 336203 320260 320264 336206 336198 336220 336221 336231 320278 336210 336179 320286 320280 336187 320279 336202 336209 320274 336208 336212 336205 320276 336215 336189 320275 336269 336230 336226 336235 32169 336224 30024 336225 52073 336247 32066 336233 336257 32172 320136 320330 336259 320341 320343 336261 336260 336268 320338 336262 336267 320339 320334 320340 336272 336270 336271 336265 320336 336211 336217 336263 336273 32000 30151 32008 32076 32061 30016 320088 320269 336223 320015 320043 320408 336777 320363 336320 336322 336313 30035 320407 336288 336314 336321 320402 336317 320400 336311 336312 336323 320403 336316 336315 320396 336318 320395 320397 320375 320405 320401 320406 336319 320404 320411 320414 320410 336056 336056 320416 320423 320421 320419 32181 320436 336327 320437 32175 336324 320409 320422 320415 320426 320333 320420 320431 320418 320417 320424 320412 336325 32176 336326 32174 336328 320413 320427 320428 320399 320429 32179 320433 320430 336329 320425 336334 320435 32178 336810 336823 336814 336813 336821 336822 336811 336812 336818 336820 336817 336816 336819 336825 336829 336824 336828 336826 336831 336827 336830 336834 336833 336832 336835 336843 336852 336855 336853 336841 336844 336842 336850 336839 336838 336837 336836 336845 336840 336849 336847 336851 336848 336856 336846 336854 336861 336863 336858 336865 336860 336857 336859 336862 336867 336864 336866 336868 336869 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Holly Wiight Lee 440-483-5777 |
Manufacturer Reason for Recall | Numerous issues related to software Brilliance iCT 4.1.6 software version.
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FDA Determined Cause 2 | Software design |
Action | Philips Medical Systems (Cleveland), Inc. sent the Customer Information Letter via certified letters mail with returned receipts. Also, a Field Service Engineer will perform the software update on the system to resolve the issues. Implementation of the software update will be monitored. |
Distribution | 26 US Govt accounts |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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