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[Recalled] 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 inten

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductDraeger 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 us
Brand / manufacturerDraeger Medical Systems, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2046-2018
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date15 May 2018

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Draeger Medical Systems, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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