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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0913-2014

Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda 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: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50681 HDJS50682 HDJS50684 HDJS50686 HDJR56405 HDJS52316 HDJP51364 HDJP51369 HDJP51376 HDJP51379 HDJP51380 HDJP51381 HDJR56387 HDJR56388 HDJR56389 HDJR56390 HDJR56391 HDJR56666 HDJN50977 HDJN50978 HDJQ53071 HDJM51282 HDJM51283 HDJM51284 HDJM51285 HDJM51286 HDJM51287 HDJM51288 HDJM51289 HDJM51290 HDJM51291 HDJM51292 HDJM51293 HDJM51294 HDJM51295 HDJQ50845 HDJQ50846 HDJQ50361 HDJQ50362 HDJQ50363 HDJQ50364 HDJQ50365 HDJQ52097 HDJM51403 HDJM51871 HDJP52195 HDJP52198 HDJP52199 HDJP52200 HDJP52201 HDJP52202 HDJP52203 HDJP52204 HDJP52205 HDJP52206 HDJP52207 HDJM50831 HDJM50832 HDJM50833 HDJS51808 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJP50315 HDJP50369 HDJP50371 HDJR58044 HDJR58045 HDJP51614 HDJP51615 HDJN52372 HDJN52373 HDJS50504 HDJS50505 HDJM50027 HDJL50483 HDJM50022 HDJM50024 HDJM50411 HDJS50708 HDJS52037 HDJR57284 HDJR57285 HDJN52002 HDJN50436 HDJN50437 HDJP50552 HDJP50553 HDJQ50808 HDJP50078 HDJP50083 HDJQ52336 HDJQ52337 HDJQ52036 HDJQ52037 HDJQ52038 HDJQ52039 HDJS51666 HDJP52689 HDJQ51784 HDJQ51785 HDJQ51786 HDJQ51787 HDJS50825 HDJS50826 HDJS50827 HDJS50828 HDJS50829 HDJS50830 HDJS50831 HDJS50832 HDJR56841 HDJR56842 HDJR56843 HDJR56844 HDJR56845 HDJR56846 HDJR56847 HDJR56848 HDJR56849 HDJR56850 HDJR56851 HDJR56852 HDJR56853 HDJS51131 HDJQ52031 HDJQ50663 HDJS50931 HDJS50932 HDJQ51956 HDJM50250 HDJM50251 HDJM50252 HDJM50253 HDJM50254 HDJM50255 HDJM52126 HDJM52127 HDJM52128 HDJM52129 HDJQ50066 HDJQ50067 HDJR50762 HDJR50763 HDJR50764 HDJR58093 HDJR58094 HDJR58095 HDJR52011 HDJR52012 HDJR54180 HDJR50307 HDJR50308 HDJR50309 HDJR50310 HDJS51721 HDJM51686 HDJM51687 HDJN51900 HDJN51901 HDJP51716 HDJS50570 HDJS50571 HDJS50572 HDJS50573 HDJM50391 HDJM50392 HDJP50523 HDJP50524 HDJP50525 HDJP50526 HDJP50527 HDJP50528 HDJL50044 HDJP50572 HDJP52345 HDJP52349 HDJP52350 HDJQ52153 HDJQ52154 HDJQ52155 HDJQ52156 HDJQ52157 HDJM50520 HDJM50521 HDJM50522 HDJN50060 HDJN50228 HDJN52440 HDJN52444 HDJN52445 HDJN52447 HDJP51831 HDJP51912 HDJP51913 HDJP51914 HDJQ51571 HDJQ51572 HDJR57384 HDJS51672 HDJS51673 HDJS51674 HDJS51675 HDJS52895 HDJP50288 HDJP50289 HDJP50290 HDJP50291 HDJP50292 HDJP50293 HDJP50294 HDJP50295 HDJP50296 HDJP50297 HDJP50298 HDJP50299 HDJP50300 HDJP50301 HDJP50302 HDJP50303 HDJP50304 HDJP50305 HDJP50306 HDJP50307 HDJP50308 HDJP50285 HDJP50286 HDJP50287 HDJM51014 HDJM51015 HDJP50825 HDJS51670 HDJS51671 HDJM51624 HDJM51625 HDJP50184 HDJS52686 HDJS52687 HDJM52321 HDJM52322 HDJR50583 HDJP5031 HDJP5037 HDJQ50506 HDJQ51178 HDJS52005 HDJR50545 HDJR50546 HDJR50547 HDJR50548 HDJR50549 HDJR50550 HDJR50551 HDJR50552 HDJR50553 HDJR50554 HDJQ50165 HDJQ50187 HDJQ50246 HDJQ50162 HDJQ50164 HDJR50593 HDJR50599 HDJS52340 HDJS52341 HDJS52342 HDJS52343 HDJS52344 HDJS52391 HDJP50656 HDJR56736 HDJR56802 HDJS52053 HDJS52272 HDJS52365 HDJM50484 HDJM50485 HDJM50486 HDJM50487 HDJP50599 HDJP50600 HDJP52608 HDJS52246 HDJS52247 HDJS52248 HDJP50428 HDJP50429 HDJP50430 HDJP50431 HDJP50432 HDJP50433 HDJP50434 HDJP50435 HDJP50436 HDJP50437 HDJP50438 HDJP50439 HDJP50440 HDJN52367 HDJN52368 HDJN52369 HDJR54333 HDJR56220 HDJN51334 HDJN51335 HDJN51336 HDJR54276 HDJN51083 HDJN51084 HDJN51616 HDJN51617 HDJN51805 HDJN51808 HDJP52219 HDJP52220 HDJR50578 HDJQ51064 HDJP50278 HDJQ52830 HDJR56726 HDJR56376 HDJR56377 HDJR56229 HDJR56230 HDJR56231 HDJR56233 HDJR56234 HDJR56235 HDJR56236 HDJR56237 HDJR56238 HDJR56239 HDJR56240 HDJR56241 HDJR56242 HDJR56243 HDJR56244 HDJR56249 HDJR56250 HDJR56292 HDJR56293 HDJR56662 HDJR56664 HDJQ52579 HDJQ52580 HDJQ52581 HDJ
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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