The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Giraffe Infant Warmers and Panda i-Res Infant Warmers
- Lot Numbers: All lots are involved.
- 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
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
- Infants who are placed in the Giraffe or Panda i-Res Infant Warmers
- Healthcare professionals using the Giraffe or Panda i-Res Infant Warmer
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:
- Inspect the bedside panels of the warmers, including the latch areas and the areas connecting the panel to the bed, for any cracks or damages. If any portion of the bedside panels or latches are cracked or broken, stop using the warmer. If the warmer bedside panels have no cracks or damage, you may continue to use the warmer.
- Apply the newly provided Safety Labels to the bedside panels of each warmer. These Safety Labels include:
- Labels that warn users of the incorrect and the correct ways to move the warmer.
- Labels that warn users to make sure the bedside panels are latched and secure.
- Provide instructional posters to staff so that they can be posted. The posters include pictures of broken and unbroken latches showing how to check the bedside panels for any damage.
- Review the Addendum to the Warmer Operation and Maintenance Manual sent with the June 14, 2019 notification letter.
- If you have the affected infant warmer, complete and return the Customer Response form by e-mail to MIC.Recall@ge.com indicating what components require replacement.
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.