Events

Rappel de Device Recall Philips Healthcare Ingenuity CT

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79666
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1405-2018
  • Date de mise en oeuvre de l'événement
    2018-02-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162954
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    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 CT
  • Modèle / numéro de série
    Serial No. : 32045 52062 30003 30004 300225 30029 30007 300220 300211 300229 300243 300209 30027 30041 30040 300247 300233 300237 300236 30038 300222 300227 300234 30038 30037 30039 30048 300240 30046 30044 30036 300215 300201 300200 336121 300202 300228 300248 30011 300214 300217 300216 300224 300242 300245 300231 300230 300226 300239 300241 30028 30042 30018 30019 30018 300238 30030 336084 333057 30043 30033 30033 30026 32109 32102 30045 300221 30017 52060 30034 30049 30047 320392 320383 310328 310313 300204 300207 300205 300203 300150 300212 300213 300206 320205 300208 300210 300219 300086 300235 300223 300232 310314 310377 336286 320247 310362 310375 338003 320434 320388 320385 320322 320396 320368 320338 320364 320346 320369 320400 320437 336147 320214 320235 320378 320297 320337 320395 310353 320339 320402 320397 310379 310370 32128 320353 320405 320401 320375 310387 310326 310340 310339 320404 310356 320382 310342 310341 320406 320409 310360 310357 310349 320426 310135 310211 310302 310328 310351 320349 310358 310352 310355 310348 310381 320389 310369 310361 310313 320372 320347 320328 320341 310333 320298 310354 320324 320354 320361 310359 333181 300218
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Ingenuity CT - Model no. 728326, 728325, 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
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA