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U.S. Department of Health and Human Services

Class 1 Device Recall Giraffe OmniBed Carestation, Giraffe OmniBed Carestation CS1

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 Class 1 Device Recall Giraffe OmniBed Carestation, Giraffe OmniBed Carestation CS1see related information
Date Initiated by FirmOctober 11, 2019
Date PostedDecember 03, 2019
Recall Status1 Terminated 3 on August 15, 2024
Recall NumberZ-0539-2020
Recall Event ID 84077
510(K)NumberK152814 
Product Classification Warmer, infant radiant - Product Code FMT
ProductGiraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
Code Information Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX Updated 6/3/2021 - All model numbers and units are affected.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
FDA Determined
Cause 2
Device Design
ActionThe firm disseminated its notices by letter beginning on 10/11/2019. The notices identified the following safety issues: - The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be upright and look closed but not be latched. - The portholes also can look closed when not latched. - If a canopy cover is used, it can hold the bedside panel or porthole door closed without being latched. The product may continue to be used following specific safety instructions outlined in the notice. On/about 11/8/2019, the firm issued an "Amended - Urgent Medical Device Recall" letter that supplemented the previous notification to provide additional safety instructions and materials (poster regarding risk of patient fall, user manual addendum, and labeling, including safety labels). Update 6/3/2021: In the event a new consignee was identified, GE Healthcare has sent the original letter.
Quantity in Commerce7814 units
Distributionworldwide
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMT
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