Draeger Medical Systems, Inc. Recall: Draeger Jaundice Meter JM-103 The device is intended
Draeger Medical Systems, Inc. Recall: Draeger Jaundice Meter JM-103 The device is intended is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Draeger Medical Systems, Inc.; Product: Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices unde
| Recalling firm | Draeger Medical Systems, Inc. |
|---|---|
| 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 |
| Reason for recall | Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | 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, Argentin |
| Recall initiated | 20180515 |
| Recall number | Z-2046-2018 |
| Category | device |
| State | PA |
| Country | United States |
$29/mo
Try RecallGuard →