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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 April 25, 2023
Date Posted July 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2258-2023
Recall Event ID 92202
510(K)Number K180015  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Incisive CT-Computed Tomography X-Ray System
Model: 728143
Code Information UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers: 33001 33002 33003 33005 33006 33007 33008 33009 33010 33011 33012 33013 33015 33016 33017 33019 33020 33024 33025 33031 33033 33034 33035 33037 33038 33039 33041 33042 33045 33046 33047 33049 500252 500255 500282 500301 OUS: System Serial Number 530117 33018 33021 33022 33023 33026 33027 33029 33030 33032 33036 33040 33043 33044 500241 500244 500245 500246 500247 500248 500253 500254 500256 500257 500258 500259 500260 500261 500262 500263 500264 500265 500266 500267 500268 500269 500270 500271 500272 500273 500274 500275 500276 500277 500278 500279 500283 500284 500285 500286 500287 500288 500293 500296 500298 500299 500300 500302 500303 500304 500305 500306 500307 500308 500309 500310 500311 500312 500313 500314 500315 500316 500317 500318 500319 500320 500321 500322 500323 500324 500325 500326 500327 500328 500329 500330 500331 500332 500333 500334 500335 500336 500337 500338 500339 500340 500341 500342 500343 500344 500345 500346 500347 500348 500349 500350 500351 500352 500353 500354 500355 500356 500357 500358 500359 500360 500361 500362 500363 500364 500365 500366 500367 500368 500369 500370 500371 500372 500373 500374 500375 500376 500377 500378 500379 500380 500381 500382 500383 500384 500385 500386 500387 500388 500389 500390 500391 500392 500393 500394 500395 500396 500397 500398 500399 500400 500401 500402 500403 500404 500405 500406 500407 500408 500409 500410 500411 500412 500413 500414 500415 500416 500417 500418 500419 500420 500421 500422 500423 500424 500425 500426 500427 500428 500429 500430 500431 500432 500433 500434 500435 500436 500437 500438 500439 500440 500441 500442 500443 500444 500445 500446 500447 500448 500449 500450 500451 500455 500456 500457 500458 500459 500460 500461 500462 500463 500464 500465 500466 500467 500468 500469 500470 500471 500472 500473 500474 500475 500476 500477 500478 500479 500480 500481 500482 500483 500484 500485 500486 500487 500488 500489 500490 500491 500492 500493 500494 500495 500497 500498 510000 510001 510002 510003 510004 510005 510006 510007 510008 510009 510010 510011 510012 510013 510014 510015 510016 510017 510018 510019 510020 510021 510022 510023 510024 510025 510026 510027 510028 510029 510030 510031 510032 510033 510034 510035 510036 510037 510038 510041 530118 530119 530120 530121 530124 530125 530126 530127 530128 530129 530130 530132 530133 530134 530135 530136 530137 530138 530139 530140 530141 530142 530143 530144 530145 530146 530147 530148 530149 530150 530151 530152 530153 530154 530155 530156 530157 530158 530159 530160 530161 530162 530163 530164 530165 530166 530167 530168 530169 530170 530171 530172 530173 530174 530175 530176 530177 530178 530179 530180 530181 530182 530183 530184 530185 530186 530187 530188 530189 530190 530191 530192 530193 530194 530195 530196 530197 530198 530199 530200 530201 530202 530203 530204 530205 530206 530207 530208 530209 530210 530211 530212 530213 530214 530215 530216 530217 530218 530219 530220 530221 530222 530223 530224 530225 530226 530227 530228 530229 530230 530231 530232 530233 530234 530235 530237 530238 530239 530240 530241 530242 530243 530244 530245 530246 530247 530248 530249 530250 530251 530252 530253 530254 530255 530256 530257 530258 530259 530260 530261 530262 530263 530264 530265 530266 530267 530268 530269 530270 530271 530272 530273 530274 530275 530276 530277 530278 530279 530280 530281 530282 530283 530284 530285 530286 530287 530288 530289 530290 530291 530292 530293 530295 530296 530297 530298 530299 530300 530302 530303 530304 530305 530306 530308 530309 530310 530311 530312 530313 530314 530315 530316 530317 530318 530319 530321 530322 530323 530324 530325 530326 530327 530328 530330 530333 530334 530336 530337 530339 530340 530341 530343 530344 530346 530347 530348 530351 530352 530353 530354 530355 530356 530359 530361 530362 530364 530365 530366 530367 530371 530375 530376 530377 530379 530380 530381 530382 530383 530385 530386 530387 530390 530391 530392 530393 530394 530395 530396 530397 530398 530399 530400 530401 530402 530403 530405 530406 530407 530410 530411 530412 530413 530414 530415 530416 530417 530418 530422 530423 530424 530425 530426 530427 530428 530429 530433 530434 530438 530439 530440 530441 530442 530443 530444 530446 530447 530448 530450 530451 530453 530454 530455 530457 530459 530463 530465 530467 530468 530469 530471 530472 530473 530477 530478 530479 530484 530487 530488 530490 530491 530493 530495 530496 530497 530498 530499 530503 530504 530522
Recalling Firm/
Manufacturer
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact Philips Customer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
FDA Determined
Cause 2
Under Investigation by firm
Action Phiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23 International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800798). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce 36 US; 610 OUS
Distribution Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan 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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