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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0912-2014

Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Publicado el 12 de febrero de 2014 · Inicio del retiro: 12 de diciembre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare
Distribuidor
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
Lote
Serial Numbers: HDJR52093 HDJQ52878 HDJS51010 HDJP51983 HDJN52273 HDJN52274 HDJN52275 HDJN52276 HDJP50604 HDJP50605 HDJM50388 HDJR56613 HDJQ52689 HDJR50734 HDJR50735 HDJS50028 HDJP52371 HDJP52558 HDJN51693 HDJN51694 HDJR56618 HDJQ51960 HDJS52390 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926 HDJQ52927 HDJQ53075 HDJR56481 HDJR56482 HDJR56486 HDJR56487 HDJR56488 HDJR56489 HDJR56490 HDJR56491 HDJR56358 HDJP50531 HDJP50532 HDJR56107 HDJR56370 HDJR56669 HDJR56746 HDJR56747 HDJR56748 HDJM51930 HDJM52089 HDJM51405 HDJM51470 HDJM51471 HDJM51472 HDJM51475 HDJM51847 HDJS51291 HDJS51292 HDJR54229 HDJQ51474 HDJQ51475 HDJQ51476 HDJM52059 HDJM50272 HDJP50634 HDJQ51827 HDJR50477 HDJR57730 HDJM50483 HDJQ52812 HDJS52096 HDJR57172 HDJM50694 HDJN51776 HDJN51777 HDJN51778 HDJQ51257 HDJR56005 HDJR56006 HDJR56007 HDJR56008 HDJQ52597 HDJQ52598 HDJQ52599 HDJQ52600 HDJQ52601 HDJN50850 HDJM50704 HDJM50705 HDJM50706 HDJM50707 HDJM50708 HDJM50709 HDJQ53073 HDJR57718 HDJP50352 HDJM50012 HDJP51078 HDJP51079 HDJP51080 HDJQ51561 HDJQ51562 HDJQ51563 HDJR56749 HDJR56750 HDJR56751 HDJR56752 HDJR56753 HDJS50790 HDJS50791 HDJS50792 HDJR57719 HDJR57720 HDJR57721 HDJQ50915 HDJQ50916 HDJQ50917 HDJQ50918 HDJQ50919 HDJS51692 HDJS51693 HDJM51900 HDJM52091 HDJM52092 HDJM52093 HDJS50046 HDJS50047 HDJS50048 HDJR50230 HDJR50231 HDJS50297 HDJP51783 HDJP51784 HDJP51792 HDJP51793 HDJP51796 HDJQ52082 HDJS50733 HDJS50734 HDJS50735 HDJP52863 HDJR50596 HDJR50597 HDJR50598 HDJN50595 HDJM50200 HDJM50201 HDJP52156 HDJP52071 HDJP52072 HDJQ52813 HDJQ52814 HDJQ52815 HDJQ52895 HDJS51414 HDJS51415 HDJS51417 HDJM51320 HDJM51321 HDJM51883 HDJN50762 HDJN50763 HDJN51327 HDJS50042 HDJS50043 HDJR50133 HDJR50134 HDJR50135 HDJR50136 HDJR50138 HDJR50139 HDJR50140 HDJR50141 HDJR50142 HDJR50144 HDJR50145 HDJR50146 HDJR50147 HDJR50148 HDJR50149 HDJR50150 HDJR50151 HDJR50152 HDJR50153 HDJR50154 HDJR50155 HDJR50156 HDJR50158 HDJR50159 HDJR50161 HDJR50143 HDJR50157 HDJR50160 HDJR50299 HDJL50161 HDJL50162 HDJL50163 HDJL50164 HDJL50165 HDJR50298 HDJS51009 HDJP50561 HDJP50562 HDJP50563 HDJP50564 HDJP50565 HDJP50566 HDJQ52690 HDJS50002 HDJS50003 HDJS50004 HDJS50005 HDJS50006 HDJS50007 HDJL50357 HDJL50358 HDJL50360 HDJL50362 HDJL50359 HDJL50383 HDJR52099 HDJR56206 HDJN51948 HDJN51949 HDJN52121 HDJN52122 HDJP52630 HDJP51794 HDJP51795 HDJP52794 HDJP52795 HDJN52437 HDJN52438 HDJN52439 HDJS52720 HDJS52721 HDJR54274 HDJR54275 HDJR52095 HDJR54268 HDJR54269 HDJR54270 HDJR54271 HDJR54272 HDJM50005 HDJM50006 HDJM50007 HDJS51006 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJN52376 HDJP50730 HDJR56133 HDJM51307 HDJS51426 HDJS51427 HDJS51458 HDJP51526 HDJP51527 HDJP51528 HDJP52796 HDJP52797 HDJP52798 HDJR56368 HDJR57717 HDJR56207 HDJL50432 HDJL50433 HDJL50434 HDJL50435 HDJQ51484 HDJQ51485 HDJQ51486 HDJQ51487 HDJQ51488 HDJQ51489 HDJQ51490 HDJM51308 HDJP50177 HDJR56361 HDJP51389 HDJP51390 HDJP51391 HDJN50262 HDJN50263 HDJN50264 HDJN50265 HDJP52079 HDJP52080 HDJP52081 HDJP52082 HDJN50541 HDJN50542 HDJN50543 HDJN50544 HDJN50545 HDJN50546 HDJN50547 HDJN50298 HDJN50299 HDJR54214 HDJR54215 HDJR54216 HDJQ50580 HDJQ50581 HDJQ50582 HDJQ50583 HDJQ50584 HDJQ50585 HDJM50056 HDJM50178 HDJM50583 HDJM51924 HDJM52339 HDJM50651 HDJR52092 HDJR52098 HDJM50058 HDJM50097 HDJN51392 HDJR58028 HDJR58029 HDJR58030 HDJR58031 HDJM50142 HDJQ50388 HDJQ50389 HDJQ53023 HDJQ53024 HDJQ53025 HDJQ53026 HDJQ53027 HDJQ53028 HDJQ53029 HDJQ53030 HDJQ53031 HDJN51333 HDJN51855 HDJN51856 HDJN51857 HDJN51858 H
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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