Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Enforcement
- Recall Number
- Z-0481-2019
- Event ID
- 81224
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Healthcare, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 28, 2018
- Initiation Date
- September 25, 2018
- Classification Date
- November 19, 2018
- Termination Date
- July 13, 2020
- Address
- 3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States
Description
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Potential electric leakage affecting the user.
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);
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.
1,724 devices total