Draeger Medical Systems recalled two models of its jaundice meter May 21 after numerous users misinterpreted the device's display methods, which resulted in serious injuries.
Here are four things to know:
1. Draeger's Jaundice Meter JM-103 and Jaundice Meter JM-105 are used to measure bilirubin, or the yellowness of subcutaneous tissue, in newborns.
2. The recall involves 2,449 JM-103 models distributed from July 2008 to September 2017 and 2,063 JM-105 models distributed from October 2013 to April 2018.
3. When a newborn's bilirubin level exceeds the meters' maximum level of detection, the devices display either three blinking dashes or a dash-zero-dash combination.
"Some users have interpreted the two display messages as indicating a 'low' or 'zero' value instead of high bilirubin levels," the FDA said in a recall alert. "When this happens, treatment may be delayed or not offered, which could lead to brain damage and possibly death in some newborns/infants."
4. Draeger started notifying customers about the issue in late May. The company also gave users device labels to remind them of the display messages' "out-of range" meaning and rolled out a software update for the JM-105 model.