Events

Rappel de Device Recall GE Ultrasound Vivid E9

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 GE Healthcare, LLC.

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
    67905
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1488-2014
  • Date de mise en oeuvre de l'événement
    2014-03-27
  • Date de publication de l'événement
    2014-04-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126587
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    Ge healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (c1-5-d, c2-9-d, ic5-9-d and m5sc-d) are incorrect. this may result in a situation where probes can overheat.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 27, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Managers of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare service representative).

Device

Device Recall GE Ultrasound Vivid E9
  • Modèle / numéro de série
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 0000000VE96008 VE9006008  0000000VE96009 VE9006009  0000000VE96010 VE9006010  0000000VE96020 VE9006020  0000000VE96022 VE9006022  0000000VE96138  0000000VE96185 VE9006185  0000000VE96186 VE9006186  0000000VE96187 VE9006187  0000000VE96188 VE9006188  0000000VE96189 VE9006189  0000000VE96190 VE9006190  0000000VE96191 VE9006191  0000000VE96193 VE9006193  0000000VE96194 VE9006194  0000000VE96210 VE9006210  0000000VE96211 VE9006211  0000000VE96212 VE9006212  0000000VE96232 VE9006232  0000000VE96233 VE9006233  0000000VE96234 VE9006234 0000000VE96235 VE9006235  0000000VE96281 VE9006281  0000000VE96282 VE9006282  0000000VE96310 VE9006310  0000000VE96312 VE9006312  0000000VE96357 VE9006357  0000000VE96359 VE9006359  0000000VE96360 VE9006360  0000000VE96361 VE9006361  0000000VE96474 VE9006474  0000000VE96475 VE9006475  0000000VE96477 VE9006477  0000000VE96566 VE9006566  0000000VE96567 VE9006567  0000000VE96568 VE9006568  0000000VE96569 VE9006569  0000000VE96570 VE9006570  0000000VE96571 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 0000000VE95929 FI1387US45  0000000VE96453 FI1034US11  0000000VE96462 FI1000US43  0000000VE96643 FI1025US25  0000000VE96944 FI1008US05  0000000VE91314 US73018013  0000000VE91824 USM9319104  0000000VE91879 USM9483807  0000000VE92151 U257035001  0000000VE92876 U172259004  0000000VE92895 USM2376712  0000000VE93593 USM4400108  0000000VE94549 USM4202407  0000000VE94550 US20005505  0000000VE94598 U191660607  0000000VE94599 U191660608  0000000VE94600 U191660609  0000000VE94684 UM41470601  0000000VE95034 U178486402  0000000VE95181 U304151801  0000000VE95182 U304151802  0000000VE95370 U289468803  0000000VE95451 US78113506  0000000VE95495 U224933302  0000000VE95620 US78034309  0000000VE95648 US55001908  0000000VE96037 USM4400115  0000000VE96096 US67500903  0000000VE96180 U217921402  0000000VE96223 US25000605  0000000VE96236 US55554116  0000000VE96237 USM4501713  0000000VE96240 U276410803  0000000VE96398 USM1464505  0000000VE96440 U235798703  0000000VE96441 US63001301  0000000VE96624 USM4024501 0000000VE96660 US25971506  0000000VE96661 US78027123  0000000VE96735 U202809302  0000000VE96744 U347517301  0000000VE96745 U304151808  0000000VE96746 U304151809  0000000VE96747 U235798704  0000000VE96934 U230344704  0000000VE96935 U230344705  0000000VE91368 145763U004  0000000VE91496 1280997U05  0000000VE92722 112093U006  0000000VE93136 110783U036  0000000VE93992 1280997U06  0000000VE94294 102014U003  0000000VE94585 148119U004  0000000VE95506 149657U047  0000000VE95971 110783U038  0000000VE95972 110783U039  0000000VE95973 110783U040  0000000VE95974 110783U041  0000000VE95975 110783U049  0000000VE95976 110783U046  0000000VE95977 110783U052  0000000VE96197 110395U003  0000000VE96239 122019U154  0000000VE96386 110016U020  0000000VE96387 110277U002  0000000VE96388 1280997U08  0000000VE96410 145769U013  0000000VE96411 2264533U02  0000000VE96412 110052U022  0000000VE96413 112032U009  0000000VE96414 144523U006  0000000VE96422 1882626U21  0000000VE96423 1937574U17  0000000VE96424 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UY9356  0000000VE94767 UYZ354  0000000VE94988 UY9380  0000000VE95011 UY9387  0000000VE95014 UY9390  0000000VE95472 UY9411  0000000VE95521 UY9412  0000000VE95522 UY9415  0000000VE95523 UY9417  0000000VE95524 UY9418  0000000VE95525 UY9419  0000000VE95527 UYA423  0000000VE95580 UY9422  0000000VE95737 UY9426  0000000VE95832 UY9434  0000000VE95861 UY9448  0000000VE95863 UY9431  0000000VE95887 UY9440  0000000VE95897 UY9445  0000000VE95898 UY9447  0000000VE95899 UY9449  0000000VE96134 UY9450  0000000VE96135 UY9456  0000000VE96136 UY9457  0000000VE96137 UY9458  0000000VE96139 UY9473  0000000VE96164 UY9466  0000000VE96165 UY9476  0000000VE96166 UY9471  0000000VE96167 UY9482  0000000VE96168 UY9477  0000000VE96201 UY9479  0000000VE96202 UY9467  0000000VE96203 UY9468  0000000VE96204 UY9469  0000000VE96205 UY9470  0000000VE96246 UY9453  0000000VE96247 UY9459  0000000VE96248 UY9474  0000000VE96249 UY9454  0000000VE96252 UY9455  0000000VE96253 UY9460  0000000VE96262 UY9461  0000000VE96288 UY9464  0000000VE96289 UY9472  0000000VE96290 UY9462  0000000VE96291 UY9465  0000000VE96292 UY9490  0000000VE96293 UY9493  0000000VE96373 UY9491  0000000VE96380 UY9475  0000000VE96466 UY9483  0000000VE96467 UY9496  0000000VE96468 UY9484  0000000VE96469 UY9478  0000000VE96470 UY9485  0000000VE96471 UY9497  0000000VE96558 UY9486  0000000VE96559 UY9487  0000000VE96605 UY9495  0000000VE96606 UY9488  0000000VE96607 UY9492  0000000VE96608 UY9489  0000000VE96779 UY9501  0000000VE96780 UY9502  0000000VE96781 UY9503  0000000VE96783 UY9505  0000000VE96784 UY9506  0000000VE96785 UY9507  0000000VE96829 UY9508  0000000VE96830 UY9509  0000000VE96832 UY9521  0000000VE96858 UY9512  0000000VE96859 UY9511  0000000VE96860 UY9510  0000000VE96861 UY9513  0000000VE96862 UY9518  0000000VE96890 UY9519  0000000VE96907 UY9522  0000000VE96917 UY9516  0000000VE96919 UY9517  0000000VE96920 UY9520  0000000VE94450 850370200 0000000VE96297 HDW02402  0000000VE92970 920369512 0000000VE90124 NO4153US04  0000000VE90447 NO4146US07  0000000VE91393 NO4011US82  0000000VE92941 NO4070US26  0000000VE94749 NO4016US63  0000000VE94750 NO4016US62  0000000VE95151 NO4011U136 0000000VE95293 NO4000US33 0000000VE95608 NO5005US42  0000000VE96195 NO4064US16 0000000VE96209 NO4013US04 0000000VE96217 NO4088US43 0000000VE96218 NO4088US44 0000000VE96335 NO4088US46 0000000VE96399 NO4155US04 0000000VE96644 NO4068US72  0000000VE96707 NO4068US73  0000000VE96755 NO4071US08  0000000VE96756 NO4110US09  0000000VE96714 PL3169US01  0000000VE95268 PER28513 0000000VE96757 PER43240  0000000VE96828 PER02553  0000000VE96931 PES16600  0000000VE96169 RU8488US01 0000000VE96216 6073UL0050  0000000VE96911 ZA2561US23  0000000VE96200 UE255934  0000000VE94024 R002US41  0000000VE95588 M047US02  0000000VE96058 FA50US57  0000000VE96627 N004US10  0000000VE96767 A022US36  0000000VE96844 G002US07  0000000VE96845 G002US06 0000000VE96847 G001US18  0000000VE90483 534551US01  0000000VE90547 547150US03  0000000VE91374 529170US09  0000000VE91375 830593US03  0000000VE92013 475200US24  0000000VE92038 720050US05  0000000VE92226 748253US01  0000000VE93801 482896US03  0000000VE94437 260010US31  0000000VE94660 475200US31  0000000VE95592 900010US68  0000000VE95738 266210US04  0000000VE95896 529050US19  0000000VE95927 260010US36  0000000VE96048 124057US01  0000000VE96151 103000US06  0000000VE96332 850020US31  0000000VE96333 529230US13  0000000VE96439 707220US05  0000000VE96672 850010US07  0000000VE96702 506463US03  0000000VE96808 534551US02  0000000VE96815 527356US02  0000000VE94534 853380306
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.
  • Description du dispositif
    GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA