Recall Z-2046-2018 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
Draeger Medical Systems, Inc.
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 in
| Date | Jun 7, 2018 (initiated May 15, 2018) |
| Status | Terminated |
| Reason | Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement. |
| Root cause | Device Design |
| Action | The firm, Drager, sent an "Urgent Medical Device Safety Notices" were distributed to customers on 5/15/18. The letter described the product, problem and actions to be taken. The letters instruct customers to perform the following: Enclosed with this letter are label/s and instructions on how and hwere to apply the label onto your device/s. Please make sure that all JM-105/JM-103 devices in your hospital are labeled according to the instructions in a timely manner. Please make sure that in your clinical environment the users are trained in the use of the equipment and the clinical workflow |
| Quantity | 10363 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042522 | JAUNDICE METER, MODEL JM 103 Draeger Medical Infant Care, Inc., Jul 6, 2005 |