Company:Draeger Medical Systems, Inc.
Date of Enforcement Report 6/13/2018
Class l:
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.
Recall Number: Z-2046-2018
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
8318
DISTRIBUTION
Nationwide and Internationally
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