Giraffe and Panda i-Res Infant Warmers Recalled

GE Issues Recall of Giraffe and Panda i-Res Infant Warmers Due to Cracking of the Bedside Panels and Latch Areas

Giraffe and Panda i-Res infant warmers

UNITED STATES – According to an online news article published by www.medtechdive.com and as reported in a public health notification published by www.fda.gov, GE Healthcare, LLC has recalled its Giraffe and Panda i-Res infant warmers after learning that the warmers can crack or break in the bedside panel and latch areas.  This can lead to serious injuries and even death.

GE Healthcare, LLC has recalled its Giraffe and Panda i-Res infant warmers following more than 300 complaints and two reported injuries. The warmers are used in the hospital setting to keep infants warm when the infants are unable to maintain their body temperature on their own.  The Giraffe infant warmers are typically used in neonatal intensive care units (NICUs) while the Panda i-Res infant warmers are typically used in the labor and delivery areas.

The affected infant warmers can crack or break in the beside panel and latch areas if the infant warmers are moved using the bedside panels instead of the front or rear handles.  While no deaths have been reported, GE received reports of two infants falling and sustaining skull fractures.  Because of the significant potential for injury or death, the United States Food and Drug Administration (FDA) has identified the infant warmer recall as “Class I,” the most serious type of recall available.

Specific Recall Information

GE provided the following information to customers regarding the specific infant warmers subject to recall:

• Device Names: Giraffe Infant Warmers and Panda i-Res Infant Warmers
• Lot Numbers: All
• Model Numbers:
  • 2063568-001-XXXXXX
  • 2063570-001-XXXXXX
  • M1112198-XXXXXX
  • M1118179-XXXXXX
• Manufacturing Dates: October 1, 2007, to February 28, 2019.
• Distribution Dates:  October 1, 2007, to February 28, 2019.
• Devices Recalled in the U.S.: 25,204
• Date Initiated by Firm: March 15, 2019