Dra: Draeger Medical Systems recalls JM-105 Jaundice Meters due to users misinterpreting blinking '-0-' as zero readings, potentially leading to incorrect newborn bilirubin assessments.
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Draeger Medical Systems recalls its JM-105 Jaundice Meters because users might mistake the blinking '-0-' display for a zero reading, which could lead to incorrect bilirubin measurements in newborns. This device is only for clinical use under physician supervision and not for home use.
The device shows a blinking '-0-' when measurements are out of range. Users might think this means a zero reading, but it actually indicates a problem with the measurement. This could lead to incorrect bilirubin assessments in newborns.
Healthcare providers using the JM-105 in hospitals, clinics, or doctor's offices. Newborns receiving care with this device are at risk if measurements are misinterpreted.
Check for the Draeger Jaundice Meter JM-105 model. This device is only for clinical use under physician supervision and not for home use.
Look for blinking '-0-' which indicates out-of-range measurements, not a zero reading.
No, the JM-105 is only intended for use in hospitals, clinics, or doctor's offices under physician supervision.
It indicates an out-of-range measurement, not a zero reading. Users may misinterpret it as a zero.
The recall does not require immediate stop use; it's a low-risk issue about misinterpretation of the display.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2047-2018 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2047-2018 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.
