According to a Fox Business report, General Electric Co. has issued a recall for kits meant to upgrade hospital equipment for resuscitating newborn babies.
Hospitals use Giraffe and Panda infant warmers to weigh and warm newborn babies. The devices includes equipment to provide oxygen if needed. Insufficient oxygen at birth can cause traumatic brain injury in infants.
According to the company, the problem is with system-upgrade kits for the resuscitation equipment. Oxygen and air wall inlet fittings, as well as the labels on the back panel, may have been reversed during assembly.
Because of that mix-up, the combination of air and oxygen the device delivers could potentially be reversed. In that case, a setting of 100 percent oxygen might deliver only 21 percent oxygen, and vice versa.
According to Fox Business, the FDA has labeled it a Class 1 recall, which applies to a situation where there is a “reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”
The resuscitation upgrades kit in question were manufactured from April 2008 to Sept. 2012. No injuries have been reported in connection to them, the report says.
Another Class 1 recall was issued for a separate piece of the Giraffe and Panda resuscitation unit in June. According to the company, a T-piece circuit used with the equipment was not able to achieve the maximum inspiratory pressure.
If you or a loved one have suffered a traumatic brain injury, check with Lopez McHugh for a free consultation to see what your legal options are.
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