GE Healthcare has issued a recall for its Giraffe Incubator, Giraffe OmniBed and the Carestations that accompany both models after determining the potential for infants to fall and sustain injuries. According to a news release posted on the U.S. Food and Drug Administration’s (FDA) website, this is a Class I recall, which means it is the most serious recall requiring immediate attention.
Details of the Recall
This recall involves bedside panels in these Giraffe products that might appear to be upright and appear to be closed, but may not be securely latched. If an infant contacts either the panel or the porthole when unlatched, it may fall open and fail to protect the infant from falling. So far, there have been six reports of infant falls that include injuries such as skull fractures, hematomas and edemas. No fatalities have been reported so far as a result of these defective infant incubators.
The affected products were manufactured between April 2008-September 2019, while GE Healthcare listed the distribution dates between April 2000-September 2019. The company has recalled 22,961 devices in the U.S. since initiating the recall on Oct. 11. GE Healthcare has told consumers that they may continue using the Giraffe products, but they need to make sure the bedside panel is latched. The porthole doors also need to be checked to ensure they are latched and that healthcare professionals are aware of the instructions for latching the panels and doors.
Past GE Incubator Recalls
This is not the first recall for GE Healthcare’s Giraffe products. In October 2013, the incubators were recalled because of components that were installed backward during assembly potentially resulting in the devices delivering inaccurate levels of oxygen that may lead to over-or under-oxygenation causing infants injuries or even death.
In July, another Class I recall was issued after GE Healthcare alerted health providers to inspect bedside panels and latch areas of all Giraffe and Panda i-Res infant warmers after 338 complaints that the panels malfunctioned. In two cases, babies fell off the warmers and suffered skull fractures, but there have been no reports of deaths.
If your child has been injured as a result of these or other products, you may be able to seek compensation for the injuries, damages, and losses. Injured victims (and their families) may be able to seek compensation for medical expenses, cost of hospitalization, surgeries, rehabilitative treatment, permanent injuries, disabilities and past and future pain and suffering. An experienced product defect lawyer will be able to help them understand their legal rights and options.
Source: https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-giraffe-incubators-and-omnibeds-due-potential-infants-fall
