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U.S. Department of Health and Human Services

Class 1 Device Recall GE Giraffe

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 Class 1 Device Recall GE Giraffesee related information
Date Initiated by FirmSeptember 03, 2024
Date PostedOctober 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0048-2025
Recall Event ID 95282
510(K)NumberK152814 K213551 
Product Classification Incubator, neonatal - Product Code FMZ
ProductGE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Code Information All models
Recalling Firm/
Manufacturer		 DATEX--OHMEDA, INC.
9900 W Innovation Dr
Wauwatosa WI 53226-4856
Manufacturer Reason
for Recall		GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.
FDA Determined
Cause 2		Use error
ActionGE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/03/2024 via Fed-Ex. The notice explained the problem with the device, safety issue, and requested the following: Download the Service Manual Addendum (5971733) from the GE HealthCare Customer Documentation Portal: https://www.gehealthcare.com/support/manuals. Inspect the heater door mounting screw on your device. If the screw is not appropriately tightened, complete steps 9 and 10 of Section 1.1 of the Service Manual Addendum (5971733).
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FMZ
510(K)s with Product Code = FMZ
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