Events

Recall of Device Recall Philips Healthcare Ingenuity Core 128

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79666
  • Event Risk Class
    Class 2
  • Event Number
    Z-1407-2018
  • Event Initiated Date
    2018-02-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162959
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    Closing the emergency stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
  • Action
    The recalling firm notified customers of the recall on February 8, 2018, via Urgent Field Safety Notice. The notice advised customers of the issue and affected products and lot numbers. Customers were advised that once the E-stop has been closed, the operator/technologist must initate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Customers were informed that a Field Service Engineer would contact them to schedule site updates to correct the issue. Customers who need further information or support were advised to contact their local Philips representative. Additionally, they may contact the Customer Care Solutions Center (1-800-722-9377.

Device

Device Recall Philips Healthcare Ingenuity Core 128
  • Model / Serial
    Serial no: 320309 336076 32104 336092 336150 336100 336228 336089 336095 336100 336116 32125 32123 336117 336120 336126 336139 336131 336149 336142 336150 336152 336161 336166 336150 336182 336203 336211 336217 336220 336221 336289 336283 336133 336145 336191 30035 345218 52073 336213 320227 320419 336188 32106 336123 336216 32117 32119 32151 66769829 320265 32144 32150 32160 32157 32159 32127 320363 32145 32129 32141 32133 32127 32168 336737 336760 336764 336766 336807 336809 320260 320268 320270 320271 320253 320276 320280 320285 320289 320291 320292 320318 320294 320316 320259 320279 320286 320326 320293 320327 320296 320290 320306 320321 320307 320311 320319 320315 320366 320390 320379 320371 320386 320323 320325 320340 320334 320329 320331 320391 320359 320384 320343 320365 320403 320374 320380 320393 320420 336800 32108 32096 32122 336802 32115 336803 32116 32114 32118 32121 32120 32126 32130 32131 32097 32129 32132 32133 32137 32134 32135 32136 32138 32142 32149 32154 32143 32145 32141 32140 336733 336734 32146 32147 32152 32161 32153 336735 32169 32148 336736 32156 32158 336738 32155 32160 336739 336740 336741 336742 32091 336743 336744 32165 336745 32163 336748 336746 32164 336747 32166 32167 32180 336749 336730 336776 336752 336777 32171 32173 336753 336754 32172 336757 336759 336756 336755 336758 336761 336762 336763 336765 336767 336768 336769 336772 336770 336756 336773 336775 336774 336779 336783 336785 336787 336786 336788 336789 336791 336793 336790 336795 336794 336799 336792 336801 336798 336796 336797 336805 336806 336808 336167 336266 32111 336104 336169 336261 32042 32111 336207 336179 336180 336267 336012 336115 3202694 320235 32179 32170 320201 320200 320220 320206 320221 320222 320262 320231 320237 320236 320254 320269 320245 320417 320275 320281 320303 320301 320288 320302 320370 320310 320313 320317 320344 320412 320367 320444 320381 320399 320411 320438 320429 320424 320358 320212 336096 320229 320266 336205 32103 336083 336115 336151 336125 32124 336147 336174 336196 336197 336212 336208 336242 336235 336253 336244 336257 336250 336265 336291 336270 336272 336288 336165 336101 336138 336151 336132 336189 336190 336215 336249 336277 320348 30025 32100 336068 32047 336128 336163 336144 32101 336246 32128 336129 336103 336067 336070 336071 336069 32101 336028 336144 336118 336112 336109 336130 336141 336286 336184 336183 336222 320239 336223 320239 336292 320335 336172 336206 336225 336227 336260 336263 336273 320099 32049 336136 336209 336153 336193 336195 336177 336285 320204 32174 336088 336106 32112 336134 336111 336119 336198 336122 336136 336137 336135 336140 336146 336155 336156 336159 336162 336181 336187 336251 336210 336214 336224 336230 336232 336243 336252 336262 336264 336287 336127 32181 336157 336218 336239 336256 336268 336282 32018 336093 336046 320342 336199 336086 336110 336108 336204 336091 336171 320238 320278 320304 320376 320432 320428 320352 336154 336160 336284 320351 320351 320215 336233 336173 336236 336170 320336 336102 32057 336219 336231 336226 32105 336085 32110 336158 320230 336168 320230 320410 336176 336087 336094 336098 336097 336124 336186 336238 336240 336255 336269 336113 32055 320237 320229 320236 336259 336237 336202 336194 336114 320355 32113 336234 336241 336258 336271 336254 336090 336105 336107 336164 336192 336175 336200 336201 336274 336247 336245 336248 336275 336276 336278 336290 336293 336279 336229 336178 32139 320228 320203 320202 320208 320219 320226 320223 320242 320284 320243 320282 320240 320257 320252 320272 320273 320274 320300 320345 320416 320377 320305 320207 320232 320216 320217 320209 320258 320356 320256 320261 320267 320312 320314 320320 320373 320360 320210 320213 320225 320218 320224 320233 320241 320234 320250 320263 320251 320277 320248 320255 320283 320295 320299 320362 320287 320357 320308 320350 320387 320392 320383 320332 336125 336185 336152 32147 32146 320229 32110 336751 336771 336815 336810 336812 336811 336813 336814 336819 336817 336816 336818 336820 336823 336821 336822 336824
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA