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Recall Observatory FDA recall evidence

Device product

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

Z-0481-2019

September 25, 2018

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 81224
Status
Terminated
Classification
Class II
Quantity
1,724 devices total
Official record key
device-enforcement:Z-0481-2019

Official wording

Reason: Potential electric leakage affecting the user.

Code information: 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);

Distribution pattern: Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential electric leakage affecting the user.