Reported Mar 5, 2014 · Terminated
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare - Giraffe¿ and Panda¿
- iRes Infant Warmer Product UsageThe 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
- Lot codes and dates
- 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,H
2,739 of 2,739 codes
HDJP50293HDJP50294HDJP50295HDJP50296HDJP50297HDJP50298HDJP50299HDJP50300HDJP50301HDJP50302HDJP50303HDJP50304HDJP50305HDJP50306HDJP50307HDJP50308HDJP50285HDJP50286HDJP50287HDJM51014HDJM51015HDJP50825HDJS51670HDJS51671HDJM51624HDJM51625HDJP50184HDJS52686HDJS52687HDJM52321HDJM52322HDJR50583HDJP5031HDJP5037HDJQ50506HDJQ51178HDJS52005HDJQ51960HDJR50545HDJR50546HDJR50547HDJR50548HDJR50549HDJR50550HDJR50551HDJR50552HDJR50553HDJR50554HDJQ50165HDJQ50187HDJQ50246HDJQ50162HDJQ50164HDJS52390HDJR50593HDJR50599HDJS52340HDJS52341HDJS52342HDJS52343
- 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,
- Amount recalled
- 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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