medical Class II Updated 2018-11-28

GE Healthcare, LLC recalls Giraffe Warmer. Device sold under the following product name

Recalled Product

Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.


Hazard / Issue

Potential electric leakage affecting the user.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number, UDI (Serial Number): M1118179-018104, Not Applicable (HDJM50056); M1118179-018118, Not Applicable (HDJM50178); M1118179-024117, Not Applicable (HDJM50583); M1118179-018118, Not Applicable (HDJM50094); M1118179-022861, Not Applicable (HDJR54165); M1118179-020841, Not Applicable (HDJM50142); M1118179-024117, Not Applicable (HDJQ50967); M1118179-024117, Not Applicable (HDJQ50971); M1118179-024117, Not Applicable (HDJQ50973); M1118179-024117, Not Applicable (HDJQ50972); M1118179-024117, Not Applicable (HDJQ50974); M1118179-022643, Not Applicable (HDJM52091); M1118179-018104, Not Applicable (HDJM50060); M1118179-150421, Not Applicable (HDJT51438); M1118179-150421, Not Applicable (HDJT51439); M1118179-022643, Not Applicable (HDJM50696); M1118179-150421, Not Applicable (HDJT51652); M1118179-022643, Not Applicable (HDJQ50385); M1118179-161255, Not Applicable (HDJT60578); M1118179-161255, Not Applicable (HDJT60576); M1118179-161255, Not Applicable (HDJT60572); M1118179-161255, Not Applicable (HDJT60584); M1118179-161255, Not Applicable (HDJT60568); M1118179-026229, Not Applicable (HDJM51309); M1118179-022643, Not Applicable (HDJM50420); M1118179-022643, Not Applicable (HDJM50419); M1118179-022643, Not Applicable (HDJM50693); M1118179-022643, Not Applicable (HDJM51718); M1118179-026229, Not Applicable (HDJM51567); M1118179-226273, Not Applicable (HDJT51359); M1118179-022393, Not Applicable (HDJM50289); M1118179-022393, Not Applicable (HDJM50288); M1118179-022861, Not Applicable (HDJM50957); M1118179-022861, Not Applicable (HDJM50956); M1118179-160267, Not Applicable (HDJT61386); M1118179-526626, 010084068210392321GBWX7019911180619 (GBWX70199); M1118179-023046, Not Applicable (HDJP52075); M1118179-023046, Not Applicable (HDJM50955); M1118179-021393, Not Applicable (HDJM50046); M1118179-021393, Not Applicable (HDJM50527); M1118179-024117, Not Applicable (HDJM50584); M1118179-559396, 010084068210392321GBWX7007211180312 (GBWX70072); M1118179-023046, Not Applicable (HDJR50514); M1118179-023046, Not Applicable (HDJM50387); M1118179-023046, Not Applicable (HDJM50386); M1118179-150421, Not Applicable (HDJT50842); M1118179-150421, Not Applicable (HDJT61375); M1118179-025977, Not Applicable (HDJQ50585); M1118179-025977, Not Applicable (HDJQ50581); M1118179-527794, 010084068210392321GBWX7017111180523 (GBWX70171); M1118179-527794, 010084068210392321GBWX7017011180523 (GBWX70170); M1118179-022861, Not Applicable (HDJM50343); M1118179-022643, Not Applicable (HDJM50695); M1118179-161255, Not Applicable (HDJT51954); M1118179-174787, Not Applicable (HDJT51358); M1118179-174787, Not Applicable (HDJT51357); M1118179-019026, Not Applicable (HDJL50356); M1118179-022643, Not Applicable (HDJP52630); M1118179-024044, Not Applicable (HDJM50573); M1118179-024044, Not Applicable (HDJM50574); M1118179-024044, Not Applicable (HDJM50572); M1118179-526477, 010084068210392321GBWW6032811170511 (GBWW60328); M1118179-019593, Not Applicable (HDJL50433); M1118179-019593, Not Applicable (HDJL50434); M1118179-019593, Not Applicable (HDJL50435); M1118179-019593, Not Applicable (HDJL50432); M1118179-018104, Not Applicable (HDJM50059); M1118179-018114, Not Applicable (HDJM50097); M1118179-026007, Not Applicable (HDJM51296); M1118179-529707, 010084068210392321GBWX7023811180627 (GBWX70238); M1118179-529707, 010084068210392321GBWX7023911180627 (GBWX70239); M1118179-022643, Not Applicable (HDJM50694); M1118179-022643, Not Applicable (HDJN51744); M1118179-022861, Not Applicable (HDJM51320); M1118179-022861, Not Applicable (HDJM51321); M1118179-526477, 010084068210392321GBWX7024211180627 (GBWX70242); M1118179-526477, 010084068210392321GBWW6032711170511 (GBWW60327); M1118179-024117, Not Applicable (HDJN52275); M1118179-018118, Not Applicable (HDJM50188); M1118179-150421, Not Applicable (HDJT50988); M1118179-254785, Not Applicable (HDJT51864); M1118179-023046, Not Applicable (HDJM50536); M1118179-023046, Not Applicable (HDJM50537); M1118179-150421, Not Applicable (HDJT50843); M1118179-018118, Not Applicable (HDJM50045); M1118179-018118, Not Applicable (HDJM50186); M1118179-018114, Not Applicable (HDJM50005); M1118179-018114, Not Applicable (HDJM50006); M1118179-018114, Not Applicable (HDJM50007); M1118179-018104, Not Applicable (HDJM50061); M1118179-018104, Not Applicable (HDJM50055); M1118179-022643, Not Applicable (HDJM50698); M1118179-022643, Not Applicable (HDJM50697); M1118179-027451, Not Applicable (HDJM51565); M1118179-027451, Not Applicable (HDJM51564); M1118179-027451, Not Applicable (HDJM51566); M1118179-242231, Not Applicable (HDJT50732); M1118179-150421, Not Applicable (HDJT50839); M1118179-150421, Not Applicable (HDJT50702); M1118179-150421, Not Applicable (HDJT50722); M1118179-023046, Not Applicable (HDJN50207); M1118179-018118, Not Applicable (HDJM50179); M1118179-018104, Not Applicable (HDJM50058); M1118179-018118, Not Applicable (HDJM50062); M1118179-018118, Not Applicable (HDJM50093); M1118179-023046, Not Applicable (HDJM50654); M1118179-025977, Not Applicable (HDJM51225); M1118179-022125, Not Applicable (HDJM50470); M1118179-018118, Not Applicable (HDJM50187); M1118179-023046, Not Applicable (HDJM50388); M1118179-023046, Not Applicable (HDJM50538); M1118179-023046, Not Applicable (HDJP51904); M1118179-150421, Not Applicable (HDJT50989); M1118179-023046, Not Applicable (HDJM51553); M1118179-023046, Not Applicable (HDJM51554); M1118179-150421, Not Applicable (HDJT50838); M1118179-018104, Not Applicable (HDJM50057); M1118179-022256, Not Applicable (HDJM50180); M1118179-018114, Not Applicable (HDJL50487); M1118179-025977, Not Applicable (HDJM51217); M1118179-025977, Not Applicable (HDJM51219); M1118179-025977, Not Applicable (HDJM51224); M1118179-025977, Not Applicable (HDJM51220); M1118179-025977, Not Applicable (HDJM51216); M1118179-025977, Not Applicable (HDJM51221); M1118179-025977, Not Applicable (HDJM51218); M1118179-025977, Not Applicable (HDJM51223); M1118179-025977, Not Applicable (HDJM51222); M1118179-044164, Not Applicable (HDJR50298); M1118179-044164, Not Applicable (HDJR56108); M1118179-026395, Not Applicable (HDJM51460); M1118179-026395, Not Applicable (HDJM51461); M1118179-022439, Not Applicable (HDJM50237); M1118179-021533, Not Applicable (HDJM50147); M1118179-027863, Not Applicable (HDJM51724); M1118179-044164, Not Applicable (HDJR50297); M1118179-044164, Not Applicable (HDJR52094); M1118179-044164, Not Applicable (HDJR52095); M1118179-044164, Not Applicable (HDJR52096); M1118179-496293, 010084068210392321GBWW6030811170510 (GBWW60308); M1118179-072924, Not Applicable (HDJQ50843); M1118179-022807, Not Applicable (HDJM50309); M1118179-235294, Not Applicable (HDJT51537); M1118179-019903, Not Applicable (HDJL50330); M1118179-019903, Not Applicable (HDJL50329); M1118179-026183, Not Applicable (HDJM51322); M1118179-067995, Not Applicable (HDJQ50334); M1118179-067995, Not Applicable (HDJQ50333); M1118179-276837, Not Applicable (HDJT50987); M1118179-100772, Not Applicable (HDJR50394); M1118179-026877, Not Applicable (HDJM51456); M1118179-026788, Not Applicable (HDJM51462); M1118179-278167, Not Applicable (HDJT51000); M1118179-246044, Not Applicable (HDJT51230); M1118179-024645, Not Applicable (HDJM50753); M1118179-024645, Not Applicable (HDJM50754); M1118179-024645, Not Applicable (HDJM50755); M1118179-023078, Not Applicable (HDJM50305); M1118179-023078, Not Applicable (HDJM50661); M1118179-023078, Not Applicable (HDJM50660); M1118179-024264, Not Applicable (HDJM50663); M1118179-024264, Not Applicable (HDJM50662); M1118179-023361, Not Applicable (HDJM50385); M1118179-025604, Not Applicable (HDJM51050); M1118179-044906, Not Applicable (HDJR50453); M1118179-022468, Not Applicable (HDJM50503); M1118179-186200, Not Applicable (HDJT50777); M1118179-186200, Not Applicable (HDJT50781); M1118179-160971, Not Applicable (HDJT50664); M1118179-160971, Not Applicable (HDJT51008); M1118179-022439, Not Applicable (HDJM50236); M1118179-343873, Not Applicable (HDJT61094); M1118179-024668, Not Applicable (HDJM50689); M1118179-525532, 010084068210392321GBWW6032011170510 (GBWW60320); M1118179-525532, 010084068210392321GBWW6033011170515 (GBWW60330); M1118179-525532, 010084068210392321GBWW6033111170515 (GBWW60331); M1118179-158967, Not Applicable (HDJT51411); M1118179-024625, Not Applicable (HDJM50688); M1118179-063038, Not Applicable (HDJQ50701); M1118179-052375, Not Applicable (HDJQ50342); M1118179-052375, Not Applicable (HDJQ51188); M1118179-066171, Not Applicable (HDJQ50128); M1118179-066171, Not Applicable (HDJQ50126); M1118179-285625, Not Applicable (HDJT51152); M1118179-030272, Not Applicable (HDJQ50874); M1118179-030272, Not Applicable (HDJQ50875); M1118179-025788, Not Applicable (HDJM51192); M1118179-024130, Not Applicable (HDJM50752); M1118179-024130, Not Applicable (HDJM51505); M1118179-024130, Not Applicable (HDJM50585); M1118179-028157, Not Applicable (HDJM51755); M1118179-025086, Not Applicable (HDJM50888); M1118179-022828, Not Applicable (HDJM50306); M1118179-181417, Not Applicable (HDJT50497); M1118179-052773, Not Applicable (HDJQ51128); M1118179-157969, Not Applicable (HDJT61086); M1118179-021221, Not Applicable (HDJM50000); M1118179-300415, Not Applicable (HDJT51840); M1118179-021221, Not Applicable (HDJM50001); M1118179-021221, Not Applicable (HDJM50002); M1118179-023156, Not Applicable (HDJM50655); M1118179-021576, Not Applicable (HDJM50043); M1118179-021576, Not Applicable (HDJM50044); M1118179-030504, Not Applicable (HDJN50129); M1118179-030504, Not Applicable (HDJN50126); M1118179-023145, Not Applicable (HDJM50323); M1118179-023156, Not Applicable (HDJM50336); M1118179-533902, 010084068210392321GBWW60349170515 (GBWW60349);
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