The FDA recently posted notice of a select recall of Draeger Medical Jaundice Meters over issues with users misinterpreting the display.
The recall affects all Draeger Medical’s Jaundice Meter JM-105 units, and has been labeled as a Class I recall, indicating the potential for serious injury or death.
The Draeger Jaundice Meter is designed for hospital use in the monitoring of newborn infants, according to an FDA notice.
The recall notice was posted due to users misinterpreting a blinking “-0-” as a zero measurement, and operating the device and delivering care based on that reading.
Draeger began notifying users of the device of the issue in May, and provided an update to the labeling of the device in order to clear up the misinterpretation, according to the FDA recall notice.