Draeger Medical Systems, Inc. recalls Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physicia…

Recall date

May 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2046-2018

FDA classification

Class I

Brand / firm

Draeger Medical Systems, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: Algeria, Argenti…

Why it was recalled

Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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