RecallRadar

FDA Device recall Z-1072-2014

GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled mann…

On 2014-03-05 the FDA classified a Class I recall of GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled mann… by Ge Healthcare, citing oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1072-2014
ClassificationClass I
Statusterminated
Initiated2013-10-01
Published2014-03-05
Last updated2026-09-13 11:53 UTC
CompanyGe Healthcare
DistributionUS

Product

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.

Reason

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

Identifiers

code_info
HDJQ52826, HDJR52093, HDJR50704, HDJR54140, HDJR54141, HDJR54142, HDJR54143, HDJQ52878, HDJS50670, HDJS50671,HDJS50672,…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, HDJM5012

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2014%22

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