FDA Device recall Z-2047-2018
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / di…
- FDA Device
- Class I
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class I recall of Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / di… by Draeger Medical Systems, citing users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2047-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-15 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Draeger Medical Systems |
| Distribution | US |
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. 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
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Identifiers
| code_info | All products |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2047-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.