Events

Retiro De Equipo (Recall) de Panda iRes Infant Warmers integrated with Nellcor SpO2

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68067
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1548-2014
  • Fecha de inicio del evento
    2014-04-02
  • Fecha de publicación del evento
    2014-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126895
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Warmer, infant radiant - Product Code FMT
  • Causa
    Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative oxygen saturation and pulse rate alarm notifications to the caregiver.
  • Acción
    GE Healthcare notified Biomedical/Clinical Engineering managers, Labor & Delivery/ NICU Nurse managers, Respiratory Therapy Managers and Directors of Risk Management by letter 04/02/2014. End users were advised that they may continue to use the system provided they follow the GE recommended actions: 1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement. 2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix 3) If the test activates a Low Pulse Rate alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service. End users were also advised that alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed. 4) If the test does NOT activate a Low Pulse Rate alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.

Device

Panda iRes Infant Warmers integrated with Nellcor SpO2
  • Modelo / Serial
    HDJR50780 HDJR50781 HDJR56911 HDJR57608 HDJR57609 HDJR57610 HDJR57611 HDJR57636 HDJR57637 HDJR57638 HDJR57692 HDJR57693 HDJR57694 HDJR57695 HDJR57696 HDJR57697 HDJR57698 HDJR57699 HDJR57700 HDJR57701 HDJR57702 HDJR57703 HDJR57704 HDJR57705 HDJR57706 HDJR57707 HDJR57784 HDJR57785 HDJR57786 HDJR57787 HDJR57788 HDJR57789 HDJR57790 HDJR57791 HDJR57792 HDJR57793 HDJR57794 HDJR57795 HDJR57925 HDJR57926 HDJR57935 HDJR57936 HDJR57937 HDJR57938 HDJR57939 HDJR57944 HDJR57948 HDJR57949 HDJR57950 HDJR57951 HDJR57952 HDJR57953 HDJR57954 HDJR57955 HDJR57956 HDJR57957 HDJR57980 HDJR57981 HDJR57985 HDJR57986 HDJR57987 HDJR57988 HDJR58013 HDJR58014 HDJR58015 HDJR58039 HDJR58040 HDJR58041 HDJR58046 HDJR58047 HDJR58076 HDJR58082 HDJR58086 HDJR58087 HDJR58088 HDJR58091 HDJR58092 HDJR58093 HDJR58094 HDJR58095 HDJR58096 HDJR58097 HDJR58098 HDJR58099 HDJR58100 HDJR58101 HDJR58102 HDJR58103 HDJR58104 HDJR58105 HDJR58106 HDJR58107 HDJR58108 HDJR58109 HDJR58110 HDJR58111 HDJR58112 HDJR58113 HDJR58114 HDJR58115 HDJR58116 HDJR58117 HDJR58118 HDJR58137 HDJR58138 HDJR58156 HDJR58157 HDJR58158 HDJR58159 HDJR58160 HDJR58161 HDJR58162 HDJR58163 HDJR58164 HDJR58165 HDJR58192 HDJR58263 HDJR58264 HDJR58265 HDJR58267 HDJR58268 HDJR58269 HDJR58270 HDJR58271 HDJR58272 HDJR58273 HDJS50008 HDJS50009 HDJS50010 HDJS50011 HDJS50012 HDJS50013 HDJS50014 HDJS50015 HDJS50017 HDJS50018 HDJS50019 HDJS50020 HDJS50025 HDJS50026 HDJS50128 HDJS50129 HDJS50133 HDJS50134 HDJS50135 HDJS50136 HDJS50137 HDJS50144 HDJS50145 HDJS50146 HDJS50147 HDJS50148 HDJS50149 HDJS50150 HDJS50151 HDJS50152 HDJS50153 HDJS50154 HDJS501555 HDJS50205 HDJS50206 HDJS50238 HDJS50240 HDJS50241 HDJS50242 HDJS50243 HDJS50244 HDJS50245 HDJS50246 HDJS50247 HDJS50248 HDJS50249 HDJS50250 HDJS50251 HDJS50252 HDJS50253 HDJS50254 HDJS50337 HDJS50430 HDJS50432 HDJS50475 HDJS50476 HDJS50599 HDJS50600 HDJS50605 HDJS50606 HDJS50608 HDJS50609 HDJS50610 HDJS50611 HDJS50650 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50680 HDJS50682 HDJS50683 HDJS50684 HDJS50685 HDJS50686 HDJS50709 HDJS50710 HDJS50711 HDJS50712 HDJS50749 HDJS50750 HDJS50751 HDJS50807 HDJS50808 HDJS50834 HDJS50931 HDJS50932 HDJS50952 HDJS50953 HDJS50954 HDJS50955 HDJS50964 HDJS50965 HDJS50966 HDJS50967 HDJS50968 HDJS50969 HDJS50970 HDJS50971 HDJS50972 HDJS50973 HDJS50974 HDJS50985 HDJS51030 HDJS51038 HDJS51039 HDJS51040 HDJS51042 HDJS51043 HDJS51046 HDJS51047 HDJS51148 HDJS51168 HDJS51187 HDJS51188 HDJS51189 HDJS51190 HDJS51191 HDJS51192 HDJS51193 HDJS51194 HDJS51195 HDJS51196 HDJS51197 HDJS51198 HDJS51199 HDJS51200 HDJS51201 HDJS51202 HDJS51203 HDJS51204 HDJS51205 HDJS51206 HDJS51207 HDJS51208 HDJS51209 HDJS51210 HDJS51211 HDJS51215 HDJS51216 HDJS51254 HDJS51259 HDJS51260 HDJS51282 HDJS51319 HDJS51372 HDJS51373 HDJS51374 HDJS51385 HDJS51386 HDJS51403 HDJS51428 HDJS51524 HDJS51525 HDJS51526 HDJS51527 HDJS51528 HDJS51529 HDJS51530 HDJS51531 HDJS51532 HDJS51533 HDJS51539 HDJS51577 HDJS51578 HDJS51579 HDJS51580 HDJS51581 HDJS51582 HDJS51583 HDJS51670 HDJS51671 HDJS51686 HDJS51735 HDJS51736 HDJS51737 HDJS51739 HDJS51741 HDJS51742 HDJS51743 HDJS51744 HDJS51747 HDJS51798 HDJS51803 HDJS51848 HDJS51849 HDJS51854 HDJS51855 HDJS51856 HDJS51857 HDJS51858 HDJS51859 HDJS51860 HDJS51861 HDJS51900 HDJS51901 HDJS51902 HDJS51903 HDJS51969 HDJS51970 HDJS51971 HDJS51972 HDJS51973 HDJS51975 HDJS51980 HDJS51981 HDJS51982 HDJS51983 HDJS51984 HDJS51985 HDJS51986 HDJS51987 HDJS51988 HDJS51989 HDJS51998 HDJS52007 HDJS52008 HDJS52009 HDJS52010 HDJS52011 HDJS52012 HDJS52013 HDJS52014 HDJS52024 HDJS52025 HDJS52026 HDJS52027 HDJS52037 HDJS52038 HDJS52134 HDJS52177 HDJS52178 HDJS52179 HDJS52180 HDJS52181 HDJS52184 HDJS52185 HDJS52186 HDJS52187 HDJS52188 HDJS52189 HDJS52190 HDJS52191 HDJS52192 HDJS52193 HDJS52194 HDJS52195 HDJS52196 HDJS52197 HDJS52198 HDJS52199 HDJS52200 HDJS52201 HDJS52202 HDJS52203 HDJS52204 HDJS52205 HDJS52206 HDJS52207 HDJS52208 HDJS52209 HDJS52227 HDJS52250 HDJS52251 HDJS52252 HDJS52253 HDJS52254 HDJS52255 HDJS52256 HDJS52273 HDJS52274 HDJS52278 HDJS52279 HDJS52280 HDJS52281 HDJS52381 HDJS52382 HDJS52383 HDJS52384 HDJS52385 HDJS52386 HDJS52388 HDJS52442 HDJS52443 HDJS52447 HDJS52495 HDJS52496 HDJS52525 HDJS52600 HDJS52601 HDJS52602 HDJS52603 HDJS52604 HDJS52605 HDJS52606 HDJS52607 HDJS52608 HDJS52609 HDJS52615 HDJS52617 HDJS52618 HDJS52698 HDJS52724 HDJS52725 HDJS52726 HDJS52727 HDJS52728 HDJS52729 HDJS52730 HDJS52731 HDJS52732 HDJS52733 HDJS52734 HDJS52735 HDJS52736 HDJS52813 HDJS52818 HDJS52819 HDJS52872 HDJS52873 HDJS52874 HDJS52924 HDJS52940 HDJS52941 HDJS52942 HDJS52957 HDJS52968 HDJS52994 HDJS52995 HDJS53145 HDJS53146 HDJS53169 HDJS53170 HDJS53209 HDJS53210 HDJS53211 HDJS53212 HDJS53213 HDJS53214 HDJS53215 HDJS53244 HDJS53245 HDJS53270 HDJS53366 HDJS53406 HDJS53407 HDJS53408 HDJS53409 HDJS53410 HDJS53411 HDJS53430 HDJS53433 HDJS53434 HDJS53439 HDJS53496 HDJS53497 HDJS53498 HDJS53499 HDJS53500 HDJS53501 HDJS53502 HDJS53503 HDJS53504 HDJS53505 HDJS53506 HDJS53507 HDJS53508 HDJS55014 HDJS55015 HDJS55050 HDJS55051 HDJS55052 HDJS55053 HDJS55054 HDJS55096 HDJS55097 HDJS55098 HDJS55123 HDJS55127 HDJS55154 HDJS55155 HDJS55156 HDJS55157 HDJS55158 HDJS55159 HDJS55160 HDJS55161 HDJS55162 HDJS55163 HDJS55164 HDJS55165 HDJS55166 HDJS55170 HDJS55171 HDJS55172 HDJS55173 HDJS55174 HDJS55175 HDJS55176 HDJS55177 HDJS55178 HDJS55179 HDJS55180 HDJS55181 HDJS55182 HDJS55183 HDJS55184 HDJS55185 HDJS55186 HDJS55187 HDJS55188 HDJS55189 HDJS55190 HDJS55191 HDJS55192 HDJS55223 HDJS55224 HDJS55230 HDJS55231 HDJS55232 HDJS55243 HDJS55255 HDJS55256 HDJT50025 HDJT50035 HDJT50040 HDJT50042 HDJT50116 HDJT50117 HDJT50118 HDJT50119 HDJT50123 HDJT50134 HDJT50135 HDJT50142 HDJT50170 HDJT50224 HDJT50229 HDJT50230 HDJT50231 HDJT50232 HDJT50233 HDJT50234 HDJT50236 HDJT50237 HDJT50238 HDJT50239 HDJT50240 HDJT50241 HDJT50250 HDJT50251 HDJT50252 HDJT50254 HDJT50255 HDJT50256 HDJT50257 HDJT50258 HDJT50259 HDJT50260 HDJT50261 HDJT50366 HDJT50367 HDJT50368 HDJT50369 HDJT50370 HDJT50371 HDJT50372 HDJT50404 HDJT50429 HDJT50467 HDJT50505 HDJT50506 HDJT50507 HDJR58083 HDJR58084 HDJR58085 HDJR58266 HDJS50474 HDJS50477 HDJS50478 HDJS50479 HDJS50480 HDJS50481 HDJS50482 HDJS50486 HDJS50487 HDJS50504 HDJS50505 HDJS50535 HDJS50574 HDJS50648 HDJS50649 HDJS51041 HDJS51258 HDJS51519 HDJS51740 HDJS52713 HDJT50112 HDJT50167 HDJT50168 HDJT50169 HDJT50171 HDJT50172 HDJT50173 HDJT50220 HDJT50221 HDJT50222 HDJT50223 HDJT50253 HDJS50601 HDJS50806 HDJS51850 HDJS53440 HDJT50113 HDJT50114 HDJT50115 HDJS51149 HDJS51150 HDJS51261 HDJT50041 HDJS50681 HDJS51904 HDJS51905 HDJS51906 HDJS51907 HDJS51908 HDJS51909 HDJS51910 HDJS51911 HDJS51912 HDJS51913 HDJS51914 HDJS51915 HDJS51916 HDJS51917 HDJS51918 HDJS51919 HDJS51920 HDJS51921 HDJS51922 HDJS51923 HDJS51924 HDJS51925 HDJS51926 HDJS51927 HDJS51928 HDJS51929 HDJS51930 HDJS51931 HDJS51932 HDJS51933 HDJS51934 HDJS51935 HDJS51936 HDJS51937 HDJS51938 HDJS51939 HDJS51940 HDJS51941 HDJS51942 HDJS51943 HDJS51944 HDJS51945 HDJS51946 HDJS51947 HDJS51948 HDJS51949 HDJS51950 HDJS51951 HDJS51952 HDJS51953 HDJS51954 HDJS51959 HDJS51960 HDJS51961 HDJS51962 HDJS53441 HDJS53442 HDJS53461 HDJS51738 HDJS50473 HDJS50627 HDJS50631 HDJS50646 HDJS50647 HDJS50713 HDJS50714 HDJS50716 HDJS50719 HDJS50720 HDJS51151 HDJS53147 HDJS53148 HDJS53462 HDJS53463 HDJS53464
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. || Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA