The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2047-2018·Announced 2018-06-13

Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings

Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices because users may misinterpret the out-of-range display as a zero measurement.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement"

Plain-English summary

Draeger Medical Systems, Inc. is recalling 6,711 units of the Draeger Jaundice Meter JM-105. The device is intended for use in hospitals, clinics, or doctor's offices under a physician's supervision to assist clinicians in monitoring newborn infants. It is not intended for home use or as a standalone diagnostic tool for hyperbilirubinemia.

The recall was initiated because users have misinterpreted the display for out-of-range measurements, indicated by a blinking "-0-", to mean a zero measurement. This misinterpretation could lead to incorrect clinical assessments.

The affected devices were distributed worldwide, including nationwide in the United States and in numerous countries across multiple continents. Consumers and healthcare facilities should stop using the affected devices and contact Draeger Medical Systems for further instructions.

The recalled product

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…
Manufacturer
Draeger Medical Systems, Inc.
Category
Medical Device — Diagnostic Equipment
Hazard
Affected units
6,711

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All products

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Draeger Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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