Ohmeda Medical: 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%).

Recall number

Z-0041-2020

Recalling firm

Ohmeda Medical

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%).

Status

Terminated

Initiated

2018-10-05

Posted

not on file

Terminated

2020-06-02

Reason

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.

Root cause

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.

Quantity

not on file

Distribution

Worldwide distribution- Domestic nationwide and foreign distribution.

Lot, serial or model codes

Giraffe OmniBeds shipped from 2000 to 2011 with Serial Numbers starting from HDGD00001 to HDGQ50183.

510(k) numbers

K993407

PMA numbers

not on file

Product code

FMZ

Firm FEI

1121732

Firm city

Laurel

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

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