medical Class I Updated 2018-06-13

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

Distribution: Nationwide (United States)
Lot/Code Info: All products
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →