UPDATE: July 16, 2019: This article has been updated with a comment from GE Healthcare.
- GE Healthcare is recalling all lots of its Giraffe and Panda i-Res infant warmers because the bedside panels and latch areas can crack or break when the unit is moved.
- Two infants fell from the warmers and sustained skull fractures, FDA said in a notice Friday. No deaths were reported. GE has received 338 complaints related to the bedside panels and latches.
- The Class I recall initiated by the company on March 15 affects 25,204 devices in the United States. The infant warmers were manufactured and distributed from Oct. 1, 2007 through Feb. 28, 2019.
The beds use radiant infrared heat to warm infants, usually in a hospital setting. GE is recalling the warmers because the bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the intended maneuvering handles. A panel with a cracked or broken latch can become disengaged and fall open, putting the infant at risk of falling out of the unit.
The Panda i-Res warmers are typically used in labor and delivery areas, and the Giraffe warmers are used in neonatal intensive care units.
GE notified customers by letter on March 15 and June 14 of the problem and included safety labels to be affixed to the bedside panels of each warmer. The labels explain the correct and incorrect ways to move the bed and warn users to make sure the panels are latched and secure after each use. Also provided were posters showing how to check bedside panels for damage, with illustrations of broken and intact latches.
The company advises customers to inspect the warmer panels, including the latch areas as well as areas connecting the panel to the bed, for any cracks or damage. GE will replace all cracked or damaged panels or latches for the Giraffe and Panda warmers.
"We take patient safety very seriously. Upon receiving reports of injury, we immediately began working with the hospitals to address the issue," Liza Smith, global communications for GE Healthcare, told MedTech Dive in an email. "To ensure units are safe to use, we are providing additional safety instructions to all hospitals with the warmers, and are replacing any damaged parts."
The warmers can continue to be used if no damage is found. Customers are also advised to review the addendum to the warmer operation and maintenance manual sent with the supplemental June 14 notice. The addendum provides additional information on proper use of the front handle to move the warmer.
The model numbers for the recalled warmers are: 2063568-001-XXXXXX, 2063570-001-XXXXXX, M1112198-XXXXXX, M1118179-XXXXXX.