United StatesGiraffe OmniBed infant incubators/warmers are affected — specifically Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1 (model 2082844-001-XXX) and certain Field Replaceable Units (models 6600-1056-400 and 6600-1461-500); affected units are identified by the manufacturer’s listed serial numbers. The recall was issued because fasteners securing the canopy soffit beneath the control panel can disengage, possibly falling into the patient compartment or allowing the soffit to loosen or detach, which could result in patient injury.
What's being recalled
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Recalling firm: GE Medical Systems, LLC, Waukesha, WI, United States.
How to identify it
Serial Numbers: HDGP50034 HDGP51018 HDGS50069 HDGS50070 HDGS50074 HDGS50077 HDGS50158 HDGS50162 HDGS52245 HDGS52286 HDGT50374 HDGT50399 HDGS50464 HDGS50560 HDGS50569 HDGS50570 HDGD50349 HDGG54079 HDGJ50278 HDGJ50281 HDGJ50390 HDGJ50391 HDGJ50394 HDGJ50400 HDGK52363 HDGM50481 HDGM50482 HDGM50483 HDGM50484 HDGM50485 HDGM50486 HDGQ50625 HDGQ50626 HDGQ50627 HDGQ50628 HDGQ50629 HDGS50369 HDGS50370 HDGS50371 HDGS50372 HDGR50086 HDGL51597 HDGG54268 HDGG54270 HDGG54410 HDGK51696 HDGL51002 HDGL51003 HDGL51004 HDGL51005 HDGL51032 HDGN50383 HDGP50522 HDGQ50763 HDGQ50882 HDGQ50884 HDGQ50886 HDGQ50887 HDGQ50901 HDGQ50902 HDGQ50903 HDGQ50904 HDGQ50905 HDGQ50906 HDGQ50907 HDGQ50908 HDGQ50909 HDGQ50910 HDGQ50911 HDGQ50912 HDGQ50913 HDGQ50917 HDGS51833 HDGU60609 HDGU60732 HDGE50297 HDGE50370 HDGE50371 HDGK51791 HDGK51792 HDGK51793 HDGK51794 HDGK51795 HDGK51804 HDGK51822 HDGK51840 HDGR50087 HDGR50088 HDGR50178 HDGR50180 HDGR50184 HDGR50185 HDGN50863 HDGN50864 HDGN50865 HDGN50866 HDGN50868 HDGN50869 HDGN50870 HDGH60335 HDGH60316 HDGH60319 HDGH60320 HDGH60321 HDGH60322 HDGH60323 HDGH60324 HDGH60326 HDGH60327 HDGH60328 HDGH60329 HDGH60330 HDGH60331 HDGH60333 HDGH60334 HDGH60403 HDGH60407 HDGH60408 HDGH60409 HDGN50867 HDGT50420 HDGK51412 HDGK51706 HDGK52164 HDGL50039 HDGL51294 HDGL51483 HDGL51486 HDGM51574 HDGM51575 HDGM51583 HDGP51029 HDGS52343 HDGS52358 HDGJ50055 HDGN50393 HDGM50726 HDGM50093 HDGM50146 HDGM50149 HDGM50151 HDGP51237 HDGP51290 HDGP51297 HDGQ51823 HDGQ51947 HDGJ51132 HDGJ51133 HDGJ51134 HDGJ51136 HDGJ51142 HDGJ51176 HDGJ51177 HDGJ51180 HDGJ51181 HDGJ51182 HDGJ51189 HDGJ51190 HDGL50080 HDGL50082 HDGL50123 HDGL50165 HDGR52333 HDGS50800 HDGS50812 HDGU60084 HDGU60087 HDGU60098 HDGU60157 HDGU60158 HDGU60162 HDGU60168 HDGU60598 HDGT50753 HDGT50754 HDGT50756 HDGT50757 HDGU60516 HDGU60520 HDGU60523 HDGU60527 HDGU60528 HDGU60533 HDGU60535 HDGU60540 HDGU60542 HDGU60543 HDGJ51045 HDGJ51079 HDGQ50791 HDGR52718 HDGR52936 HDGL51165 HDGL51190 HDGM51272 HDGM51289 HDGN51296 HDGN51337…
The hazard
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
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