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U.S. Department of Health and Human Services

Class 2 Device Recall Giraffe Omnibed

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  Class 2 Device Recall Giraffe Omnibed see related information
Date Initiated by Firm October 05, 2018
Create Date October 04, 2019
Recall Status1 Terminated 3 on June 02, 2020
Recall Number Z-0041-2020
Recall Event ID 81419
510(K)Number K993407  
Product Classification Incubator, neonatal - Product Code FMZ
Product Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Code Information Giraffe OmniBeds shipped from 2000 to 2011 with Serial Numbers starting from HDGD00001 to HDGQ50183.
Recalling Firm/
Manufacturer		 Ohmeda Medical
8880 Gorman Rd
Laurel MD 20723-5800
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
FDA Determined
Cause 2		 Labeling design
Action On October 5, 2018, the recalling firm notified affected customers of the product issue via an Urgent Medical Device Correction letter. Customers were instructed to do the following: You can continue to use your Giraffe OmniBed systems in open Bed warmer mode and incubator mode. Care should be taken to achieve visible cleanliness during the cleaning process. Design of the Giraffe OmniBed allows for your facilities normal cleaning to be performed, following the step by step procedure to remove the canopy seal to reach visible debris accumulation. Contact your Biomedical department to perform the removal and reassembly of the original seal fasteners, per the attached addendum, prior to performing the cleaning procedure. Attention to cleaning technique by personnel involved in the cleaning process will reduce the likelihood of occurrence of the mentioned condition. "Carefully follow the additional instructions provided to ensure continued safe use of the device and place the addendum in your User Manual. "Always follow your facility guidelines for cleaning and infection control. GE Healthcare will provide a Giraffe OmniBed Cleaning & Care Guidelines poster for display by your system. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Distribution Worldwide distribution- Domestic nationwide and foreign distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMZ and Original Applicant = OHMEDA MEDICAL
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