Company:Draeger Medical Systems, Inc.
Date of Enforcement Report 6/13/2018
Class l:
PRODUCT
Draeger Jaundice Meter JM-105 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. Recall Number: Z-2047-2018
REASON
Users have misinterpreted the display for out of range measurement indicated by the blinking” —” to mean a zero measurement.
RECALLING FIRM/MANUFACTURER
Draeger Medical Systems, Inc., Telford, PA on 5/15/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6711
DISTRIBUTION
Nationwide and Internationally