In response to manufacturing issues surrounding its Panda and Giraffe infant warmers, GE Healthcare has launched a “voluntary field corrective action” initiative to recall affected devices. According to a regulatory filing with the United States Food and Drug Administration, patients could be at risk due to poor labeling and manufacturing errors. GE Healthcare won’t be directly recalling affected devices; instead, it will be installing an “upgrade kit” to fix the problem.
According to GE Healthcare, both the Panda and Giraffe infant warmers feature the company’s resuscitation systems with an air blender. During manufacture, the labeling on the back of the units may have been reversed. This could lead to improper oxygen / air mixtures. In some cases, this could lead to excessive oxygenation or oxygen deprivation.
This recall follows another serious manufacturing flaw with the infant warmers. GE Healthcare is also replacing the T-piece circuits that are used in both the Panda and Giraffe devices. According to the company, the devices may not provide sufficient inspiratory pressure.
For the latest recall, the company has been alerting customers to the risk since October. The initial outreach effort included an information packet on how to inspect the device. Field service engineers have been actively pursuing follow-up cases regarding the device. According to information from the company, GE manufactured the faulty resuscitation systems from April of 2008 to September of 2012.
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