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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 see related information
Date Initiated by Firm October 11, 2019
Date Posted December 03, 2019
Recall Status1 Open3, Classified
Recall Number Z-0540-2020
Recall Event ID 84077
510(K)Number K152809  
Product Classification Warmer, infant radiant - Product Code FMT
Product Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
Code Information Giraffe Incubator Carestation, Model Numbers:2082844-002-XXXXXX 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 Contact GE 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		 Use error
Action The 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 11/8/2020, 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 Commerce 3467 units
Distribution worldwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
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