Class I recall for GE Healthcare infant warmer beds

Medical Devices

The possibility of side panels and latches cracking, breaking or opening has led to GE Healthcare recalling two infant warmer hospital devices. All models of the Panda iRes and the Giraffe warmer are affected by the recall which will amount to around 25,204 devices manufactured and sold in the U.S. since 2007. The FDA has reported there have been 338 complaints about the devices, fortunately no deaths reported, but there were two separate incidents of infants falling from warmers and fracturing their skulls, so this recall has been given the highest designation of a Class 1 due to the potential for severe injuries or fatalities.

“GE Healthcare is recalling two infant warmer hospital devices. All models of the Panda iRes and the Giraffe warmer are affected.“

The problem arises when the warmers are moved using the side panels rather than the handles, as the latches can break under the stress, which GE Healthcare advised customers of in March. In June an update on the recall was communicated with the instruction to stop using any warmer with damaged panels or latches, and new caution labels and instructions on how to move the device correctly and safely using the handles provided. A GE Healthcare representative said: “We take patient safety very seriously. Upon receiving reports of injury, we immediately began working with the hospitals to address the issue. 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.”

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