Infant Warmer Recall
Written by Faith Anderson on February 7, 2013
Recalled Devices Could Cause Serious Injury or Death
GE Healthcare warned consumers in October 2012 about potential issues affecting the field upgrade kits for the company’s resuscitation systems with blenders, which are installed in the GE Giraffe and Panda infant warmers. However, in a notice issued by the FDA on January 31, 2013, the agency declared that the action constitutes a Class I medical device recall. Class I is the most serious type of recall instituted by the FDA, and describes “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.” According to the FDA, the oxygen and air wall inlet fitting and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, the air/oxygen mixer concentrations could potentially be reversed, rendering the settings of the blender knob inaccurate. For example, a setting of 100% oxygen could have an output of only 21% oxygen, and vice versa.
FDA Recommendations for Affected Customers
The Class I recall affects the field upgrade kits for GE Healthcare’s resuscitation systems with blender, installed in GE Panda and Giraffe infant warmers. The recalled system upgrade kits were manufactured from April 2008 to September 2012. GE began notifying customers in possession of recalled units by sending an “Urgent Medical Device” letter in October, which consisted of instructions to allow hospital personnel to inspect and correct the faulty device. GE field service engineers have inspected units at roughly 89% of the identified customer sites, and the remaining unconfirmed customers are being contacted in order to schedule a GE inspection. Customers with affected products are advised to stop using the device immediately and contact GE Healthcare to schedule an inspection and mitigation.