The FDA slapped GE Healthcare ($GE) with a Class I recall--its most serious designation--for some of its infant resuscitation devices after the company discovered some life-threatening malfunctions.
Giraffe Warmer and Panda Warmer Resuscitation Systems were designed to resuscitate infants and newborns and to regulate body temperature. On Nov. 18, GE Healthcare sent an Urgent Medical Device Correction letter to customers after discovering that oxygen and air wall inlet fittings on the back panel of the systems were reversed during assembly, interfering with oxygen delivery. The error could lead to low or high blood oxygen--and potentially death--in neonates, the FDA said in its recall.
This is not the first time a recall of a GE product was hit with the agency's Class I status: The company recalled T-piece circuits used with its Panda and Giraffe devices in December 2012 after the FDA said the malfunctioning components could result in injury or death. GE had first notified customers in June that the circuits did not produce sufficient inspiratory pressure, leaving patients at risk. In February 2013, the company took "voluntary field corrective action" for its infant resuscitation systems after it found that oxygen and air wall inlet fittings and/or labels on the back panel could have been reversed during assembly.
The FDA urges healthcare professionals and consumers to report any adverse reactions or problems related to the Giraffe Warmer and Panda Warmer devices through an online MedWatch program, or by regular mail or fax.
- here's the recall notice