Infant radiant warmers provide infrared heat in a controlled manner to infants who are unable to maintain their body temperature on their own. Radiant heat from an infrared heat source is focused onto the bed to warm the infant. The primary users of the device are infants in a hospital setting. Panda i-Res warmers are typically used in hospital Labor and Delivery areas while Giraffe Infant Warmers are typically used in Neonatal Intensive Care Units (NICUs).
Reason for Recall
GE Healthcare is recalling the Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle (see figures below). If an infant comes in contact with a bedside panel with a cracked or broken latch, the panel can disengage and fall open, no longer protecting the infant from falling from the warmer.
The firm has received a total of 338 complaints related to bedside panels/latches. This includes two infants who fell from warmers and fractured their skulls. There were no deaths reported.
Who May be Affected
What to Do
On March 15, 2019, GE Healthcare (GEHC) sent an Urgent Medical Device Correction notification letter to customers. Then, on June 14, 2019, GEHC posted a press release and sent an updated notification letter. These letters included Safety Labels and posters and advised customers to take the following actions:
Customers with questions or concerns regarding this recall may contact GE Healthcare Service at 1-800-437-1171 or they can call their local Service Representative.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178. Health care professionals employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
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