Recall Z-2047-2018— Draeger Medical Systems, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical Systems, Inc., initiated 2018-05-15, terminated 2023-02-08. It names one FDA 510(k) clearance: K133175. 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.
- Recalling firm
- Draeger Medical Systems, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-05-15
- Terminated
- 2023-02-08
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Data sourced from openFDA. This site is unofficial and independent of the FDA.