Draeger Medical Systems, Inc. recalls Draeger Jaundice Meter JM-103 The device is intended for
Recalled Product
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications
Hazard / Issue
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
Issued by
FDA
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