Dra: Draeger Medical Systems recalls JM-103 jaundice meters due to users misinterpreting blinking "---" as zero readings, risking incorrect newborn bilirubin assessments.
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
Draeger Medical Systems recalls the JM-103 jaundice meter because users may misread the blinking "---" display as a zero reading, leading to incorrect bilirubin measurements in newborns. This could cause improper treatment decisions if the device is used in medical settings without proper interpretation.
The device shows a blinking "---" when measurements are out of range. Users may mistakenly think this means a zero reading, leading to incorrect bilirubin assessments in newborns. This could result in improper treatment decisions if healthcare providers rely on the device without understanding the display correctly.
Healthcare providers using the JM-103 in hospitals, clinics, or doctor's offices for newborn bilirubin monitoring. Newborns receiving care with this device are at risk of incorrect treatment if the display is misinterpreted.
The JM-103 jaundice meter is used in hospitals, clinics, or doctor's offices under physician supervision. It is not intended for home use and only for sternum measurements in medical settings.
Review the device's display to confirm that blinking "---" indicates an out-of-range measurement, not a zero reading.
No, the device is not intended for home use and only for medical settings under physician supervision.
The blinking "---" indicates an out-of-range measurement, not a zero reading.
Yes, but users must correctly interpret the blinking "---" as an out-of-range measurement to avoid incorrect bilirubin assessments.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2046-2018 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2046-2018 from Draeger. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
