FDA Announces Recall of Defective Medical Device

The U.S. Food and Drug Administration (FDA) and medical device manufacturer, GE Healthcare, announced they are conducting a voluntary recall on the field upgrade kit for resuscitation systems with blenders installed in Giraffe and Panda infant warmers. An FDA press release stated use of the device could compromise a patient’s safety.

The GE Giraffe and Panda Infant Warmers are used to deliver a mixture of gases into a child’s respiratory system. Experts say that during assembly using the field upgrade kit, the oxygen, and air wall inlet fittings and/or the associated labels may have been reversed. This can lead to a reversal of air and oxygen concentrations and could render the blender knob to control these settings as inaccurate.

GE Healthcare has already begun to contact those who are known to be in possession of the Defective Medical Device and are asking that anyone with one of the devices to stop using it immediately until an inspection of the unit can be conducted by a GE field service technician.

The FDA has labeled their actions a Class I recall, considering the problems could directly result in a user of the product being injured or killed.

The Connecticut Personal Injury Lawyers with Carter Mario Law Firm know how dangerous using a defective medical device can be. That’s why the firm urges anyone who has been harmed by the use of such a defective product to look into their legal rights by discussing their case with a qualified attorney.