Events

Rappel de Device Recall Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.

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
    76805
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1779-2017
  • Date de mise en oeuvre de l'événement
    2017-03-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154231
  • 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 become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. there have been no injuries reported because of this issue.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 76164,76168 dated March 10, 2017. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering, & Managers of Radiology / Managers of Cardiology. The letter described the safety Issue, Safety Instructions, Affected Product Detail, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
  • Modèle / numéro de série
    Mfg. Lot or Serial # System ID 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95R000110 AU00111 VE95R000111 AU00113 VE95R000113 AU00117 VE95R000117 AU00118 VE95R000118 AU00120 VE95000120 AU00121 VE95R000121 AU00123 VE95R000123 AU00124 VE95R000124 AU00125 VE95R000125 AU00126 VE90000126 AU00127 VE95R000127 AU00128 VE95R000128 AU00132 VE90000132 AU00133 VE95R000133 AU00135 VE90000135 AU00138 VE95R000138 AU00159 VE95R000159 AU00160 VE9500160 AU00162 VE95000162 AU00165 VE95000165 AU00168 VE95000168 AU00171 VE90000171 AU00172 VE95R000172 AU00173 VE90000173 AU00174 VE90000174 AU00176 VE95000176 AU00182 VE95000182 AU00183 VE90000183 AU00184 VE95R000184 AU00206 VE9500206 AU00207 VE95U00207 AU00211 VE9500211 AU00224 VE90000224 AU00230 VE95000230 AU00231 VE90000231 AU00232 VE90000232 AU00240 VE95R000240 AU00242 VE95000242 AU00243 VE90000243 AU00246 VE95V000246 AU00258 VE90000258 AU00277 VE95R000277 AU00281 VE95000281 AU00287 VE95000287 AU00300 VE95000300 AU00302 VE95R000302 AU00321 VE9500321 AU00329 VE95000329 AU00330 VE95000330 AU00331 VE9500331 AU00332 VE95000332 AU00335 VE95R000335 AU00339 VE9500339 AU00347 VE95000347 AU00348 VE95000348 AU00352 VE95000352 AU00359 VE9500359 AU00360 VE95000360 AU00361 VE95000361 AU00363 VE95000363 AU00367 VE95000367 AU00368 VE95000368 AU00369 VE95000369 AU00370 VE95000370 AU00372 VE95000372 AU00373 VE95000373 AU00374 VE9500374 AU00376 VE95R00376 AU00388 VE95000388 AU00396 VE95000396 AU00398 VE95000398 AU00401 VE95000401 AU00407 VE95R000407 AU00417 VE95000417 AU00426 VE95000426 AU00429 VE95000429 AU00430 VE95000430 AU00434 VE95000434 AU00438 VE9500438 AU00439 VE95000439 AU00441 VE95000441 AU00446 VE90000446 AU00448 VE95000448 AU00450 VE9500450 AU00454 VE95000454 AU00457 VE95000457 AU00460 VE95000460 AU00465 VE95000465 AU00466 VE95000466 AU00468 VE95000468 AU00474 VE95000474 AU00478 VE95000478 AU00482 VE95000482 AU00486 VE95000486 AU00488 VE90000488 AU00494 VE95000494 AU00499 VE95000499 AU00501 VE90000501 AU00505 VE95000505 AU00509 VE95000509 AU00512 VE95000512 AU00517 VE90000517 AU00521 VE90000521 AU00527 VE95000527 AU00531 VE9500531 AU00532 VE95000532 AU00550 VE95000550 AU00551 VE90000551 AU00552 VE95000552 AU00554 VE95000554 AU00565 VE95000565 AU00568 VE90000568 AU00571 VE9500571 AU00574 VE95000574 AU00575 VE95000575 AU00577 VE95000577 AU00580 VE95000580 AU00581 VE95000581 AU00582 VE90000582 AU00586 VE95000586 AU00590 VE95000590 AU00592 VE95000592 AU00593 VE90000593 AU00595 VE95000595 AU00598 VE95000598 AU00601 VE90000601 AU00602 VE95000602 AU00605 VE90000605 AU00608 VE9500608 AU00610 VE90000610 AU00616 VE90000616 AU00618 VE9500618 AU00621 VE95000621 AU00624 VE95000624 AU00625 VE95000625 AU00628 VE9000628 AU00630 VE95000630 AU00633 VE95000633 AU00661 VE95000661 AU00667 VE90000667 AU00684 VE95000684 AU00685 VE95R000685 AU00694 VE90000694 AU00700 VE95000700 AU00707 VE95000707 AU00714 VE95000714 AU00720 VE95000720 AU00722 VE95000722 AU00728 VE95000728 AU00733 VE95000733 AU00734 VE95000734 AU00736 VE95000736 AU00744 VE90000744 AU00747 VE95000747 AU00757 VE95000757 AU00761 VE95000761 AU00762 VE95000762 AU00767 VE95000767 AU00768 VE95000768 AU00769 VE90000769 AU00770 VE95000770 AU00773 VE95000773 AU00775 VE95000775 AU00779 VE95000779 AU00780 VE95000780 AU00783 VE95000783 AU00784 VE95000784 AU00789 VE95000789 AU00795 VE90000795 AU00808 VE90000808 AU00817 VE95000817 AU00820 VE95000820 AU00821 VE95000821 AU00836 VE95000836 AU00838 VE90000838 AU00849 VE90000849 AU00852 VE95000852 AU00853 VE90000853 AU00858 VE95000858 AU00862 VE95000862 AU00863 VE95000863 AU00864 VE95000864 AU00865 VE95000865 AU00866 VE95000866 AU00872 VE95000872 AU00873 VE95000873 AU00875 VE95000875 AU00878 VE95000878 AU00884 VE95000884 AU00888 VE95000888 AU00895 VE95000895 AU00913 VE95000913 AU00924 VE95000924 AU00942 VE95R000942 AU00944 VE95000944 AU00950 VE95000950 AU00952 VE95000952 AU00953 VE95000953 AU00959 VE95R000959 AU00965 VE95000965 AU00970 VE95000970 AU00972 VE95000972 AU00977 VE95000977 AU00979 VE95000979 AU00981 VE95000981 AU00982 VE95000982 AU00988 VE95R000988 AU00993 VE95R000993 AU00994 VE95000994 AU00995 VE95000995 AU00996 VE95000996 AU00997 VE95R000997 AU01001 VE95001001 AU01008 VE95001008 AU01010 VE95001010 AU01011 VE95001011 AU01012 VE95001012 AU01016 VE95001016 AU01017 VE95001017 AU01022 VE95001022 AU01024 VE9501024 AU01025 VE95001025 AU01028 VE95001028 AU01030 VE95001030 AU01032 VE95001032 AU01033 VE95001033 AU01041 VE95001041 AU01042 VE95001042 AU01043 VE95001043 AU01046 VE95001046 AU01050 VE95V001050 AU01053 VE95001053 AU01057 VE95001057 AU01058 VE95001058 AU01063 VE95001063 AU01070 VE95001070 AU01071 VE95001071 AU01079 VE95001079 AU01091 VE90001091 AU01094 VE95001094 AU01096 VE95001096 AU01097 VE95001097 AU01100 VE95001100 AU01106 VE95001106 AU01108 VE95001108 AU01111 VE95001111 AU01113 VE95001113 AU01115 VE95001115 AU01116 VE95001116 AU01119 VE90V001119 AU01122 VE95001122 AU01124 VE95001124 AU01129 VE9001129 AU01136 VE95001136 AU01138 VE90001138 AU01140 VE90R001140 AU01141 VE9001141 AU01145 VE90V01145 AU01147 VE90001147 AU01148 VE90R001148 AU01149 VE90001149 AU01158 VE95001158 AU01161 VE95001161 AU01165 VE95001165 AU01173 VE95001173 AU01174 AM155RY647 AU01175 VE95001175 AU01176 VE95001176 AU01177 VE95001177 AU01178 VE95001178 AU01179 VE95R001179 AU01181 VE95001181 AU01184 VE95001184 AU01189 VE95001189 AU01190 VE95001190 AU01191 VE95001191 AU01192 VE95R001192 AU01194 VE95001194 AU01195 VE95001195 AU01197 VE90001197 AU01199 VE95001199 AU01206 VE95001206 AU01207 VE95001207 AU01208 VE95001208 AU01211 VE95001211 AU01214 VE95001214 AU01217 VE95001217 AU01245 VE90V01245 AU01249 VE95001249 AU01256 VE95001256 AU01257 VE95001257 AU50001 VE95050001 AU50002 VE95050002 AU50022 VE95050022 AU50033 VE90050033 AU50037 VE95R050037 AU50041 VE95050041 AU50046 VE95050046 AU50049 VE95050049 AU50052 VE95050052 AU50053 VE95050053 AU50054 VE95050054 AU50056 VE95050056 AU50057 VE95050057 AU50059 VE95050059 AU50062 VE95050062 AU50064 VE95050064 AU50072 VE95050072 AU50074 VE95050074 AU50077 VE95050077 AU50090 VE95050090 AU50097 VE95050097 AU50107 VE95050107 AU50107 VE95050107 AU50108 VE95050108 AU50114 VE95050114 AU50116 VE95050116 AU50117 VE90R00050117 AU50119 VE95050119 AU50126 VE95R050126 AU50128 VE95050128 AU50131 VE90050131 AU50136 VE95R050136 AU50137 VE90050137 AU50138 VE90R050138 AU50139 VE95050139 AU50140 VE95050140 AU50141 VE90050141 AU50143 VE95050143 AU50146 VE95050146 AU50148 VE95050148 AU50151 VE95050151 AU50153 VE95050153 AU50157 VE95050157 AU50162 VE95050162 AU50166 VE95050166 AU50167 VE95050167 AU50168 VE90050168 AU50170 VE95050170 AU50174 VE90050174 AU50177 VE95050177 AU50178 VE95050178 AU50180 VE95050180 AU50181 VE95050181 AU50182 VE95050182 AU50184 VE95050184 AU50188 VE95050188 AU50189 VE95050189 AU50190 VE95050190 AU50191 VE950050191 AU50192 VE95050192 AU50195 VE95050195 AU50198 VE90050198 AU50199 VE9050199 AU50200 VE95050200 AU50201 VE95050201 AU50202 VE90R050202 AU50203 VE95050203 AU50204 VE95050204 AU50205 VE95050205 AU50207 VE95050207 AU50208 VE90050208 AU50209 VE90050209 AU50212 VE95050212 AU50214 VE95050214 AU50216 VE95050216 AU50218 VE95050218 AU50228 VE95050228 AU50248 VE95050248 AU50256 VE95050256 AU50275 VE9050275 AU50292 VE90050292 AU50306 VE95050306 AU50307 VE95050307 AU50308 VE95050308 AU50312 VE95R050312 AU50320 VE95050320 AU50321 VE95R0050321 AU50333 VE95050333 AU50351 VE9050351 AU50358 VE95050358 AU50360 VE9050360 AU50361 VE95050361 AU50362 VE90050362 AU50363 VE95050363 AU50364 VE95050364 AU50365 VE95050365 AU50366 VE95050366 AU50367 VE95050367 AU50371 VE95050371 AU50372 VE95050372 AU50373 VE95050373 AU50374 VE95050374 AU50375 VE95050375 AU50376 VE95050376 AU50379 VE95050379 AU50382 VE95050382 AU50383 VE90050383 AU50384 VE95050384 AU50386 VE95050386 AU50389 VE95050389 AU50421 VE95000421 AU50463 VE95000463 AU50469 VE95000469 AU50471 VE95000471 AU50473 VE95000473 AU50484 VE95000484 AU50370 5973UL0647 AU00436 20208ULT03  AU00698 IE1560US17 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  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia, Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria, Australia, Argentina, Vietnam. Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan, Indonesia, Guadeloupe, Czech Republic
  • Description du dispositif
    Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
  • 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