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FDAFDA · Food and drugs·Recall number Z-1072-2014

GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.

Published March 5, 2014 · Recall initiated: October 1, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare, LLC
Distributor
Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.
Lot
HDJQ52826, HDJR52093, HDJR50704, HDJR54140, HDJR54141, HDJR54142, HDJR54143, HDJQ52878, HDJS50670, HDJS50671,HDJS50672, HDJS50678, HDJS50679, HDJS50681, HDJS50682, HDJS50684, HDJS50686, 208600, 208601, 208610, HDJS51010, HDJR56405, HDJS52316, HDJP51364, HDJP51369, HDJP51376, HDJP51379, HDJP51380, HDJP51381, HDJR56387, HDJR56388, HDJR56389, HDJR56390, HDJR56391, HDJR56666, HDJN50977, HDJN50978, HDJP51983, 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, HDJN52273, HDJN52274, HDJN52275, HDJN52276, HDJP50604, HDJP50605, HDJM50831, HDJM50832, HDJM50833, HDJS51808, HDJM50053, HDJM50054, HDJM50098, HDJM50099, HDJM50101, HDJM50103, HDJM50105, HDJM50124, HDJM50388, 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, HDJR56613, HDJQ52689, 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, HDJR50734, HDJR50735, HDJR50762, HDJR50763, HDJR50764, HDJR58093, HDJR58094, HDJR58095, HDJS50028, 206180, HDJR52011, HDJR52012, 206581, HDJR54180, HDJR50307, HDJR50308, HDJR50309, HDJR50310, HDJS51721, HDJP52371, HDJP52558, HDJM51686, HDJM51687, HDJN51900, HDJN51901, HDJP51716, HDJS50570, HDJS50571, HDJS50572, HDJS50573, HDJM50391, HDJM50392, HDJN51693, HDJN51694, HDJR56618, 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 HDJQ51960 HDJR50545 HDJR50546 HDJR50547 HDJR50548 HDJR50549 HDJR50550 HDJR50551 HDJR50552 HDJR50553 HDJR50554 HDJQ50165 HDJQ50187 HDJQ50246 HDJQ50162 HDJQ50164 HDJS52390 HDJR50593 HDJR50599 HDJS52340 HDJS52341 HDJS52342 HDJS52343 HDJS52344 HDJS52391 HDJP50656 HDJR56736 HDJR56802 HDJS52053 HDJS52272 HDJS52365 HDJM50484 HDJM50485 HDJM50486 HDJM50487 HDJP50599 HDJP50600 HDJP52608 HDJS52246 HDJS52247 HDJS52248 209359 209551 209560 HDJP50428 HDJP50429 HDJP50430 HDJP50431 HDJP50432 HDJP50433 HDJP50434 HDJP50435 HDJP50436 HDJP50437 HDJP50438 HDJP50439 HDJP50440 HDJN52367 HDJN52368 HDJN52369 HDJR54333 HDJR56220 HDJN51334 HDJN51335 HDJN51336 HDJR54276 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52
Risk classification
Class I
Area (FDA)
device
Country
United States

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